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| Tracking Information | |||||
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| First Received Date ICMJE | January 21, 2000 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | October 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004190 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer | ||||
| Official Title ICMJE | A Phase I(Limited)/Phase II Study of Oxaliplatin (OXAL) and Gemcitabine (GEMZAR) in Patients With Metastatic Pancreatic Carcinoma | ||||
| 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 combining gemcitabine and oxaliplatin in treating patients who have refractory locally advanced or metastatic pancreatic cancer. |
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| Detailed Description | OBJECTIVES: I. Determine the safety and tolerability of gemcitabine plus oxaliplatin in patients with refractory metastatic or locally advanced pancreatic cancer (phase I portion of the study closed as of 7/5/00). II. Determine the objective tumor response rate to this combination regimen in this patient population. OUTLINE: This is a dose escalation and efficacy study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 immediately followed by oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks. Patients achieving stable disease, partial response, or regressive disease continue with therapy. Patients achieving complete response for two consecutive evaluations receive an additional 2 courses of therapy. Phase I (closed as of 7/5/00): Cohorts of 3-6 patients receive escalating doses of gemcitabine and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Phase II: Patients receive the MTD of gemcitabine and oxaliplatin as in phase I. Patients are followed every 3 months for 1 year, and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 32-52 patients (12 patients to phase I (phase I closed as of 7/5/00) and 20-40 to phase II) will be accrued for this study within approximately 11-28 months. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Pancreatic Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Alberts SR, Townley PM, Goldberg RM, Cha SS, Sargent DJ, Moore DF, Krook JE, Pitot HC, Fitch TR, Wiesenfeld M, Mailliard JA. Gemcitabine and oxaliplatin for metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group phase II study. Ann Oncol. 2003 Apr;14(4):580-5. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically confirmed ductal or undifferentiated primary pancreatic cancer for which no standard curative therapy exists Progressive locally advanced disease after combined chemotherapy and radiotherapy OR Not a candidate for combined therapy OR Metastatic disease No islet cell, acinar cell, or cystadenocarcinomas Measurable or evaluable disease No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina No cardiac arrhythmia Other: No other uncontrolled illness No active infection No allergy to platinum compounds, gemcitabine, or antiemetics No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No evidence of neuropathy except preexisting grade I or II Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy, including cisplatin or gemcitabine, for radiosensitization in locally advanced disease No prior cisplatin or gemcitabine for locally advanced disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 25% or more of bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents |
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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, Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004190 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067431, NCCTG-984351 | ||||
| Study Sponsor ICMJE | North Central Cancer Treatment Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2007 | ||||
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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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