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S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003018
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : January 3, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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. 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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: dipyridamole Drug: fluorouracil Drug: leucovorin calcium Drug: mitomycin C Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 1997
Actual Primary Completion Date : January 2002
Actual Study Completion Date : January 2007

Arm Intervention/treatment
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:
  • Persantine
  • NSC-515776

Drug: fluorouracil
200 mg/m^2/day, continuous IV, Days 1-28 of 5 week cycle
Other Names:
  • 5-fluorouracil
  • 5-FU
  • NSC-19893

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:
  • Mutamycin
  • NSC-26980

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: One year ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003018

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: William H. Isacoff, MD Jonsson Comprehensive Cancer Center
Publications of Results:
Isacoff WH, Benedetti J, MacDonald JS, et al.: Continuous infusion (CI) 5 fluorouracil (5FU), leucovorin (LV), mitomycin C (Mito C) and dipyridamole (D) in patients with locally advanced unresectable pancreatic adenocarcinoma - a phase II trial of the Southwest Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-544, 2002.

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Responsible Party: Southwest Oncology Group Identifier: NCT00003018    
Other Study ID Numbers: CDR0000065599
S9700 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: April 22, 2004    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: January 2013
Keywords provided by Southwest Oncology Group:
stage II pancreatic cancer
stage III pancreatic cancer
duct cell adenocarcinoma of the pancreas
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Protective Agents
Vitamin B Complex
Antibiotics, Antineoplastic
Alkylating Agents