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Results for “Clinical Trials, Phase II as Topic”

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PubMed2002

Anti-angiogenic strategies and vascular targeting in the treatment of lung cancer.

The generation of new blood vessels, angiogenesis, is important for tumour proliferation and metastasis. This involves a number of interacting processes and factors, such as growth factors and the receptor tyrosine kinases, matrix metalloproteinases and integrins. Studies have shown that tumour vascularity and the overexpression of growth factors and their receptors are of independent prognostic importance in different cancers, including lung cancer. The present article provides a background to angiogenesis and describes the potential targets for anti-angiogenic and vascular targeting strategies in cancer, focusing specifically on carcinoma of the lung. It also describes the anti-angiogenic drugs presently under phase I, II and III investigation and highlights some of the problems associated with the standard methodologies for assessing tumour response and drug efficacy using these agents.

Angiogenesis Inducing Agents↗

PubMed2002

Tipifarnib (Janssen Pharmaceutica).

Janssen is developing tipifarnib (formerly known as R-1 15777), an inhibitor of RAS farnesylation, for the potential treatment of neoplasia [287030], [289610]. Janssen commenced clinical trials in the US, in conjunction with the National Cancer Institute, in April 1997 [287030], [289610], and by May 1999, phase II trials in patients with advanced non-small cell lung cancer were being planned [325960]. By February 2001, phase III trials for the potential treatment of pancreatic cancer and leukemia had been initiated [399065], and by June 2001, it was in phase II trials for RAS-dependent solid tumors [412618]. In November 2001, Credit Lyonnais Securities predicted NDAfilings in 2002 and 2003 for pancreatic cancer and other cancers, respectively, and projected US introductions for these indications in 2004 and 2005, respectively [436939].

Alkyl and Aryl Transferases↗

PubMed2002

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program.

Prospective clinical trials are the gold standard for evidence-based methodology used to support changes in the practice of medicine. Clinical researchers, regulatory agencies, payers, and the public embrace the conduct of phase I, II, and III clinical trials as integral to improving patient care. The National Cancer Institute (NCI) funds a number of cooperative oncology groups to conduct such clinical trials in the United States. In order to protect enrolling patients, the NCI requires expedited reporting to allow rapid identification of severe side effects on NCI-sponsored clinical trials. However, chemotherapy drugs frequently cause predictable side effects, the rapid reporting of which would potentially overwhelm the system. This article describes the development and documents the performance of a real-time toxicity reporting system implemented by the North Central Cancer Treatment Group. The goal of this system is to supplement the currently required NCI adverse event monitoring procedures and to permit study teams to identify the need to modify ongoing clinical trials. The system has proven its value in the monitoring of phase II and III trials, including trial N9741, a three-arm, phase III, advanced colorectal cancer chemotherapy study exploring combinations of irinotecan, oxaliplatin, and fluorouracil. We believe the methods described present opportunities for improving patient safety in clinical research.

Adverse Drug Reaction Reporting Systems↗

PubMed1994

Taxol (paclitaxel): a novel anti-microtubule agent with remarkable anti-neoplastic activity.

Taxol (paclitaxel), an anti-microtubule agent extracted from the needles and bark of the Pacific yew tree Taxus brevifolia, has shown a remarkable anti-neoplastic effect in human cancer in phase I studies and early phase II and III trials thus far conducted. This has been reported primarily in advanced ovarian and breast cancer, although significant activity has also been documented in small-cell and non-small-cell lung cancer, head and neck cancers, and with lower activity in metastatic melanoma. The clinical utilization of Taxol had been previously somewhat restricted by its limited availability, a limitation that has recently been overcome by combined efforts of pharmaceutical, agricultural, and governmental agencies. In this review we shall address the pre-clinical data which have led to the use of Taxol in man, the main clinical results thus far obtained, the toxicities associated with its use, current ongoing trials and future clinical directions of this promising agent.

Animals↗

PubMed1995

An overview of pharmacoepidemiology.

Pharmacoepidemiology is the application of epidemiological principles and methods to the study of drug effects in human populations. The goal of this discipline is to characterize, control and predict the effects and uses of pharmacological treatment modalities. Pharmacoepidemiology is also concerned with the economic impact and health benefits of unintended drug effects. The increasing importance of pharmacoepidemiology has been created by the need to develop a more accurate portrait of how drugs are used in the general population. Sophisticated and potent drug therapies require surveillance beyond the scope of the carefully controlled clinical trials of Phases I, II and III. Case-control and cohort studies, which allow scientists to evaluate the effects of patient variables on clinical outcomes, provide a wealth of information regarding the study of unexpected drug effects, drug utilization, treatment costs and the individualization of therapy.

Case-Control Studies↗

PubMed2003

Innovative strategies in lymphoma therapy.

Treatment of malignant non-Hodgkin lymphomas (NHL) in the 21st century has been revolutionized by novel biological agents offering targeted approaches in addition to radio-chemotherapy. Monoclonal antibodies (MoAbs) against lymphatic surface antigens have been effective as monotherapeutic agents, and have already shown their superiority to conventional strategies when combined with chemotherapy. Radioimmunoconjugates are more effective than unlabelled antibodies. Specific inhibitors of neoangiogenesis as well as intracellular signal transduction pathways and antiapoptotic mechanisms have shown their efficacy in phase II studies. Long-term improvement in the setting of minimal residual disease has been observed after vaccination against surface antigens and non-myeloablative allogeneic stem cell transplantation is effective in controlling lymphoma growth. Novel specific antigens are currently identified using expression profiling of lymphomas. In the near future, combinations of biological agents will challenge conventional therapy. These exciting new strategies will improve the success rate in aggressive NHLs and may even challenge the paradigm of incurability of indolent lymphomas.

Alemtuzumab↗

PubMed2001

Measuring the incremental cost of clinical cancer research.

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute-sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

Clinical Trials as Topic↗

PubMed2003

Participation of patients 65 years of age or older in cancer clinical trials.

PURPOSE: Although 61% of new cases of cancer occur among the elderly, recent studies indicate that the elderly comprise only 25% of participants in cancer clinical trials. Further investigation into the reasons for low elderly participation is warranted. Our objective was to evaluate the participation of the elderly in clinical trials sponsored by the National Cancer Institute (NCI) and assess the impact of protocol exclusion criteria on elderly participation. PATIENTS AND METHODS: We conducted a retrospective analysis using NCI data, analyzing patient and trial characteristics for 59,300 patients enrolled onto 495 NCI-sponsored, cooperative group trials, active from 1997 through 2000. Our main outcome measure was the proportion of elderly patients enrolled onto cancer clinical trials compared with the proportion of incident cancer patients who are elderly. RESULTS: Overall, 32% of participants in phase II and III clinical trials were elderly, compared with 61% of patients with incident cancers in the United States who are elderly. The degree of underrepresentation was more pronounced in trials for early-stage cancers than in trials for late-stage cancers (P <.001). Furthermore, protocol exclusion criteria on the basis of organ-system abnormalities and functional status limitations were associated with lower elderly participation. We estimate that if protocol exclusions were relaxed, elderly participation in cancer trials would be 60%. CONCLUSION: The elderly are underrepresented in cancer clinical trials relative to their disease burden. Older patients are more likely to have medical histories that make them ineligible for clinical trials because of protocol exclusions. Insurance coverage for clinical trials is one step toward improvement of elderly access to clinical trials. Without a change in study design or requirements, this step may not be sufficient.

Aged↗

PubMed2004

Statistics in clinical trials.

Statistical developments over the past several years are described in this review. Efforts in phase I studies have focused on efficient estimation of maximum tolerated dose. Issues investigated for phase II trials include incorporation of multiple endpoints and randomization. For phase III trials, methods to reduce time or use the sample size more efficiently have been investigated. However, design innovations come with costs, including possible increased risk of incorrect conclusions. Other recent challenging statistical developments in clinical trials relate to use of complementary outcomes such as quality of life and to associated biologic questions, including the emergence of the field of genomics.

Clinical Trials as Topic↗

PubMed2000

Irinotecan in the management of patients with pancreatic cancer.

Synergy with no overlapping toxicities has been demonstrated for the combination of irinotecan (Camptosar, CPT-11) and gemcitabine (Gemzar) in vitro. Results of a single-institution phase I study in which patients with previously untreated pancreatic cancer were given irinotecan and gemcitabine were promising, with two of three patients achieving a partial response. Because of the favorable outcome of the phase I study, a multicenter phase II trial was undertaken in previously untreated patients with pancreatic carcinoma. Data from other sites entering patients in this phase II study have been analyzed, and a multicenter phase III trial of single-agent gemcitabine vs the irinotecan combination in first-line treatment of patients with locally advanced or metastatic pancreatic cancer is underway.

Antineoplastic Agents, Phytogenic↗

PubMed1998

[Quantitative bibliographic analysis of French clinical research in the treatment of bronchopulmonary cancer].

A retrospective analysis by searching Medline to assess various criteria regarding the quality of publications in recent years in the treatment of bronchial cancer in France. Following some pre-defined principles for inclusion, 103 references corresponding to 90 papers were retained for this study. The data analysed had been the method of publication (45 abstracts and 58 articles), the origin of the study based on the place and the specialty of the first signatory to publication, the subject of the study (42 out of the 90 studies were on chemotherapy), the population of the patient studies (56 concerned non small cell cancer), the methodology of the study which most often used the rules for open phase II trials and only 13 times was it a phase III study, also the number of patients included was recorded. A tentative interpretation of the weak and strong points of French lung cancer research was carried out based on this analysis and has led to the proposition for the creation of a confederation of clinical research in this area.

Abstracting and Indexing↗

PubMed1999

Human studies of recombinant human nerve growth factor and diabetic peripheral neuropathy.

Recombinant human nerve growth factor (rhNGF) is the first neurotrophin to be investigated in clinical trials of diabetic peripheral neuropathy (DPN). To date, the drug has been administered to 60 healthy volunteers and 209 patients with DPN in phase I and II studies. Results from phase I have demonstrated rhNGF to be safe and generally well tolerated in doses up to 1.0 microg/kg given intravenously or subcutaneously for up to 12 doses. Doses investigated in phase II were 0.1 or 0.3 microg/kg s.c. 3 days a week for 6 months. Preliminary results from this trial suggest that rhNGF specifically improves the function of small-fibre sensory peripheral neurons, which is consistent with its postulated mode of action. Two pivotal 12-month phase III trials are underway in diabetic patients with symptomatic peripheral neuropathy to confirm the therapeutic effects of rhNGF. Results from these trials are expected in 2000.

Adult↗

PubMed2001

[Standard therapy of CPT-11 for colorectal cancer].

Irinotecan (CPT-11) is a potent inhibitor of topoisomerase I, and has demonstrated antitumor activity against metastatic colorectal cancer. In phase II studies, CPT-11 showed promising activity. Combining irinotecan with 5-fluorouracil (5-FU) and Leucovorin (LV) has shown benefits for patients with metastatic colorectal cancer CPT-11/5-FU/LV therapy is considered as a standard therapy. Weekly or biweekly administration of CPT-11 is most recommended.

Antineoplastic Agents, Phytogenic↗

PubMed2002

Eptifibatide in percutaneous coronary intervention. A review.

Percutaneous coronary angioplasty and stenting is widely used for the treatment of patients with coronary artery disease. Glycoprotein (GP) IIb-IIIa inhibitors represent a new class of drugs with proven efficacy in reducing ischemic complications of patients undergoing percutaneous coronary intervention (PCI). One of these, eptifibatide (Integrilin feminine, COR), is a small molecule inhibitor of glycoprotein IIb-IIIa receptors which has been studied extensively in patients undergoing PCI. In both IMPACT II and ESPRIT trials, patients treated with eptifibatide experienced a reduction in the rate of ischemic complications compared to those treated with placebo. These landmark studies, which are the focus of this review, emphasize the importance of considering the use of GP IIb-IIIa inhibitors in all patients undergoing PCI.

Adult↗

PubMed2005

Partial breast irradiation after breast-conserving surgery.

BACKGROUND: The standard technique of postoperative radiotherapy after breast-conserving surgery is percutaneous irradiation of the entire breast to a total dose of 45-50 Gy which is usually followed by a tumor bed boost. Since the majority of local recurrences in selected patients occur close to the former tumor bed, the question arises whether a sole tumor bed irradiation might be a therapeutic alternative to total breast irradiation. METHODS: A systematic review of relevant literature concerning partial breast irradiation (PBI) up to November 2004 was undertaken. Studies of any design were included for comparison and discussion. RESULTS: Nine unique brachytherapy studies using the multi-catheter technique, one the balloon technique (MammoSite), and eight particular intraoperative radiotherapy (IORT) trials were located of which only one was a randomized trial. Only minor postoperative complications were reported. Preliminary results are similar in terms of local tumor control, disease-free and overall survival. However, the current evidence base of IORT studies is poor. CONCLUSION: Despite controversies regarding PBI after breast-conserving surgery, results of phase I-II trials suggest that sole tumor bed irradiation might be an appropriate therapeutic alternative for selected breast cancer patients. However, more experience and data from ongoing phase III trials are required to define these new methods to be an appropriate treatment option. Therefore, total breast irradiation still remains the standard irradiation modality even in the treatment of early breast cancer, and PBI should be considered investigational.

Adult↗

PubMedDate not supplied

Innovative antineoplastic agents.

Cancer treatment options are changing as a result of extensive research efforts. New drugs and drug combinations proceed through specific phases of clinical research leading to possible Food and Drug Administration review and approval. Phase I, II, III, and IV clinical trials have detailed enrollment criteria and treatment plans designed to determine research objectives. These objectives can include reduction of toxicity, increased efficacy, and improved quality of life. Liposomal drug formulations, monoclonal antibody therapies, and cytoprotective agents are some of the new treatment approaches that have shown promise in clinical trials. This article reviews the clinical trial process, several innovative therapies, and the nursing responsibilities associated with caring for the patient with cancer.

Antibodies, Monoclonal↗

PubMed2002

Overview of clinical trials with epidermal growth factor receptor inhibitors in advanced non-small cell lung cancer.

OBJECTIVES: To provide an overview of the clinical development of ZD1839 and other epidermal growth factor receptor (EGFR) inhibitors in the treatment of advanced non-small cell lung cancer (NSCLC). DATA SOURCES: Research articles and abstracts. CONCLUSIONS: Increased understanding of cancer biology has led to the development of multiple targeted agents to evaluate clinically in the treatment of various cancers. The EGFR inhibitors appear promising in the treatment of NSCLC. ZD1839 has shown activity and symptom and quality-of-life improvements in two large phase II trials. Ongoing and future trials will continue to explore the optimal use of ZD1839 and other EGFR inhibitors in the treatment of NSCLC. IMPLICATIONS FOR NURSING PRACTICE: Several investigational EGFR inhibitors are likely to become commercially available over the next few years. Nurses should be knowledgeable regarding these agents to provide appropriate patient and family education and to assure safe drug delivery.

Biopsy, Needle↗

PubMed2004

Micafungin.

OBJECTIVE: To review the pharmacology, mycology, chemistry, in vitro susceptibility, pharmacokinetics, clinical efficacy, safety, tolerability, dosage, and administration of micafungin, an echinocandin antifungal agent. DATA SOURCES: A MEDLINE search, restricted to English language, was conducted from 1978 to November 2003. Supplementary sources included program abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America from 1996 to 2003 and information available through the manufacturer's Web site. STUDY SELECTION AND DATA EXTRACTION: In vitro and preclinical studies, as well as Phase II and III clinical trials, were evaluated to summarize the clinical efficacy and safety of micafungin. All published and unpublished trials and abstracts citing micafungin were selected. DATA SYNTHESIS: Micafungin has shown in vitro activity against many yeasts and a variety of molds. Micafungin can be administered only parenterally. Efficacy has been illustrated in open noncomparative studies of esophageal candidiasis in HIV-infected patients and in comparative trials as antifungal prophylaxis in patients undergoing hematopoietic stem-cell transplantation. Adverse events appear mild and limited; the most commonly reported adverse events include hyperbilirubinemia, nausea, and diarrhea. CONCLUSIONS: Micafungin has activity against Aspergillus spp. and a variety of Candida spp., including azole-resistant strains. Micafungin demonstrates efficacy in the treatment of esophageal candidiasis in HIV-infected patients and appears superior to fluconazole as antifungal prophylaxis in patients undergoing hematopoietic stem-cell transplantation. Based on case reports and in vitro efficacy, micafungin may prove to be a clinically useful agent in the treatment of other fungal diseases; however, these indications await the results of clinical trials.

Antifungal Agents↗