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

November 1, 1999
January 2, 2013
September 1997
January 2002   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: One year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003018 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • 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
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)
Interventions:
  • Drug: dipyridamole
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Drug: mitomycin C

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
January 2007
January 2002   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003018
CDR0000065599, S9700, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: William H. Isacoff, MD Jonsson Comprehensive Cancer Center
Southwest Oncology Group
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP