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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003018
First received: November 1, 1999
Last updated: January 2, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • 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

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003018

  Show 84 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: William H. Isacoff, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
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.

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:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Dipyridamole
Fluorouracil
Levoleucovorin
Mitomycin
Mitomycins
Alkylating Agents
Antibiotics, Antineoplastic
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Cardiovascular Agents
Enzyme Inhibitors
Hematologic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014