S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
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Purpose
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. Chemotherapy following surgery may be an effective treatment for pancreatic cancer.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: dipyridamole Drug: fluorouracil Drug: leucovorin calcium Drug: mitomycin C |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients With Locally Advanced Unresected Pancreatic Adenocarcinoma |
- Overall Survival [ Time Frame: One year ] [ Designated as safety issue: No ]
- Response rate in patients with measurable disease [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ] [ Designated as safety issue: No ]
- Toxicities [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ] [ Designated as safety issue: Yes ]
- Resectability of patents who respond to this regimen [ Time Frame: From date of registration until the date of patients achieving complete or partial response assessed up to 100 months ] [ Designated as safety issue: No ]
| Enrollment: | 54 |
| Study Start Date: | September 1997 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Chemotherapy
dipyridamole: 75mg/dose, PO, Days 1-28 of 5 week cycle; fluorouracil: 200 mg/m^2/day, continuous IV, Days 1-28 of 5 week cycle; leucovorin calcium: 30 mg/m^2/day, IV, Days 1,8,15,22 of 5 week cycle; mitomycin C: 10 mg/m^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
|
Drug: dipyridamole
75mg/dose, PO, Days 1-28 of 5 week cycle
Other Names:
Drug: fluorouracil
200 mg/m^2/day, continuous IV, Days 1-28 of 5 week cycle
Other Names:
Drug: leucovorin calcium
30 mg/m^2/day, IV, Days 1,8,15,22 of 5 week cycle
Other Name: NSC-3590
Drug: mitomycin C
10 mg/m^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
Other Names:
|
Detailed Description:
OBJECTIVES: I. Assess the one year overall survival rate of patients with advanced, unresectable pancreatic cancer treated with fluorouracil, leucovorin, mitomycin and dipyridamole. II. Assess the response rate in this group of patients. III. Evaluate the frequency and severity of the toxic effects associated with this therapy. IV. Assess the rate of resectability in patients who respond to therapy.
OUTLINE: All patients undergo surgical placement of an indwelling central venous line. Patients receive fluorouracil IV by continuous infusion on days 1-28, leucovorin calcium IV on days 1, 8, 15, and 22, oral dipyridamole on days 1-28, and mitomycin IV every 6 weeks starting on day 1. Treatment repeats every 6 weeks for 4 courses. Patients with a partial or complete response are reevaluated for possible surgical resection. Resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks. Patients are followed every 6 months for 2 years, then annually until death.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage II or III pancreatic adenocarcinoma Ductal adenocarcinoma Mucinous noncystic carcinoma Signet ring cell carcinoma Adenosquamous carcinoma Undifferentiated (anaplastic) carcinoma Mixed ductal-endocrine carcinoma Well differentiated adenocarcinoma Moderately well or poorly differentiated adenocarcinoma Undifferentiated ductal carcinoma Must have unresectable and localized disease Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Loss of no greater than 15% of actual body weight Oral intake of greater than 1,200 calories per day No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer that is currently in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy for pancreatic cancer Surgery: At least 2 weeks since prior surgical bypass procedure and recovered
Contacts and Locations
Show 84 Study Locations| Study Chair: | William H. Isacoff, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003018 History of Changes |
| Other Study ID Numbers: | CDR0000065599, S9700, U10CA032102 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage II pancreatic cancer stage III pancreatic cancer duct cell adenocarcinoma of the pancreas |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Mitomycins Mitomycin Fluorouracil |
Dipyridamole Calcium, Dietary Leucovorin Levoleucovorin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Bone Density Conservation Agents Physiological Effects of Drugs Phosphodiesterase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013