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| Sponsored by: |
Janssen Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005648 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine combined with R115777 is more effective than gemcitabine alone for pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without R115777 in treating patients who have advanced pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: tipifarnib |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Phase III, Double-Blind, Placebo Controlled Trial of Gemcitabine Plus Placebo Versus Gemcitabine Plus R115777 in Patients With Advanced Pancreatic Cancer |
| Study Start Date: | November 1999 |
OBJECTIVES: I. Compare the overall survival of patients with advanced pancreatic cancer after treatment with gemcitabine with or without R115777. II.
Compare quality of life in these patients with these treatment regimens. III. Compare objective response rate, progression free survival, and duration of objective response with these treatment regimens in these patients. IV. Estimate 6 month and 1 year survival rates in these patients after these treatment regimens. V. Assess the safety of these treatment regimens in these patients. VI. Determine the incidence of ras mutations in these patients with these treatment regimens.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive R115777 orally every 12 hours in combination with gemcitabine IV over 30 minutes weekly for 7 weeks followed by 1 week of rest. Subsequent gemcitabine is given weekly for 3 weeks followed by 1 week of rest. Arm II: Patient receive gemcitabine as in arm I. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 4 weeks on study, every 2 months in the first year, and then every 3 months for up to 5 years or until start of further treatment. Patients are followed every 2 months for the first year and then every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study over 13.2 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Pathologically confirmed, locally advanced, unresectable or metastatic adenocarcinoma of the pancreas Measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminase no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within past 6 months, congestive heart failure, unstable angina, clinically significant pericardial disease, or clinically significant arrhythmia) Other: No concurrent or prior malignancy within past 5 years except superficial basal cell carcinoma of the skin No other concurrent disease that may preclude study No known hypersensitivity to imidazole derivatives Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception For more information regarding this protocol, please call 1-888-773-9831. Approximately 90-100 United States and international centers are participating.
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No other prior chemotherapy At least 6 months since prior fluorouracil as a radiosensitizer Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Surgery: See Disease Characteristics Other: No other systemic therapy for pancreatic cancer At least 30 days since prior other investigational drugs No concurrent proton pump inhibitors (e.g., omeprazole, lansoprazole, and pantoprazole)
Contacts and Locations| United States, New Jersey | |
| Janssen Research Foundation | |
| Titusville, New Jersey, United States, 08560-0200 | |
| University Hospital/New Jersey Cancer Center | |
| Newark, New Jersey, United States, 07103 | |
| Study Chair: | Kim Boericke | Quintiles Oncology Therapeutics |
More Information
| Study ID Numbers: | CDR0000067838, JRF-R115777-INT-11 |
| Study First Received: | May 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005648 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
|
Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Immunosuppressive Agents Antiviral Agents Pancrelipase Recurrence |
Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms Tipifarnib |
|
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms Tipifarnib |
