Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | October 16, 2012 | ||||
| Start Date ICMJE | August 1995 | ||||
| Primary Completion Date | May 2000 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00002955 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas | ||||
| Official Title ICMJE | Modulation of 5-Fluorouracil With Trimetrexate and Leucovorin in Advanced Pancreatic Cancer | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with advanced cancer of the pancreas. |
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| Detailed Description | OBJECTIVES: I. Evaluate tumor response to a trimetrexate, fluorouracil and leucovorin regimen in patients with advanced pancreatic carcinoma. II. Evaluate the toxicities associated with this regimen in patients with metastatic carcinoma of the pancreas. OUTLINE: The treatment plan consists of an IV infusion of trimetrexate, followed 24 hours later by IV infusions of leucovorin and fluorouracil. After another 24 hours oral leucovorin will be given every 6 hours for 7 doses. A treatment cycle consists of the regimen repeated weekly for 6 weeks followed by 2 weeks of rest. Treatment cycles will be repeated until disease progression or unacceptable toxicity. PROJECTED ACCRUAL: If 3 or more complete or partial responses are observed in the first 22 patients, an additional 11 patients may be accrued for a maximum of 33. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE | Pancreatic Cancer | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Garcia AA, Leichman L, Baranda J, et al.: Phase II study of trimetrexate (neutrexin), 5-fluorouracil and leucovorin (NFL) in advacne pancreatic. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A971, 253a, 1999. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 21 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | May 2000 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically proven advanced pancreatic cancer with metastatic disease Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT, SGPT and alkaline phosphatase less than 3 times upper limit of normal Serum albumin at least 3.0 g/dL Renal: Serum creatinine no greater than 1.5 mg/dL Other: Not eligible for higher priority protocol No prior malignancy within 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective birth control No underlying medical condition precluding treatment PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy No prior radiotherapy to only site(s) of measurable disease Fully recovered from therapy Surgery: Fully recovered from prior surgery |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00002955 | ||||
| Other Study ID Numbers ICMJE | CDR0000065428 (3P-95-1), LAC-USC-3P951, NCI-G97-1173 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | USC/Norris Comprehensive Cancer Center | ||||
| Study Sponsor ICMJE | USC/Norris Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | USC/Norris Comprehensive Cancer Center | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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