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

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003018
Collaborator
National Cancer Institute (NCI) (NIH)
54
Enrollment
84
Locations
1
Arm
112
Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Sep 1, 1997
Actual Primary Completion Date :
Jan 1, 2002
Actual Study Completion Date :
Jan 1, 2007

Arms and Interventions

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 Names:
  • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [One year]

    Secondary Outcome Measures

    1. Response rate in patients with measurable disease [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 [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 [From date of registration until the date of patients achieving complete or partial response assessed up to 100 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - University of South Alabama Mobile Alabama United States 36688
    2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
    3 Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona United States 85012
    4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    5 Arizona Cancer Center Tucson Arizona United States 85724
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
    8 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    9 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033-0800
    10 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    11 Beckman Research Institute, City of Hope Los Angeles California United States 91010
    12 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    13 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    14 Chao Family Comprehensive Cancer Center Orange California United States 92868
    15 University of California Davis Medical Center Sacramento California United States 95817
    16 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    17 David Grant Medical Center Travis Air Force Base California United States 94535
    18 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    19 University of Colorado Cancer Center Denver Colorado United States 80262
    20 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    21 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    22 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    23 CCOP - Central Illinois Decatur Illinois United States 62526
    24 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    25 Loyola University Medical Center Maywood Illinois United States 60153
    26 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    27 CCOP - Wichita Wichita Kansas United States 67214-3882
    28 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    29 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
    30 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    31 MBCCOP - LSU Medical Center New Orleans Louisiana United States 70112
    32 Tulane University School of Medicine New Orleans Louisiana United States 70112
    33 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
    34 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    35 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
    36 Boston Medical Center Boston Massachusetts United States 02118
    37 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    38 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    39 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    40 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    41 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    42 Henry Ford Hospital Detroit Michigan United States 48202
    43 CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    44 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
    45 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
    46 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    47 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    48 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    49 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
    50 CCOP - Kansas City Kansas City Missouri United States 64131
    51 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    52 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    53 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    54 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    55 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    56 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    57 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    58 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    59 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    60 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    61 CCOP - Columbus Columbus Ohio United States 43206
    62 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
    63 CCOP - Dayton Kettering Ohio United States 45429
    64 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
    65 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
    66 Oregon Cancer Center at Oregon Health Sciences University Portland Oregon United States 97201-3098
    67 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    68 CCOP - Columbia River Program Portland Oregon United States 97213
    69 CCOP - Greenville Greenville South Carolina United States 29615
    70 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    71 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    72 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    73 University of Texas Medical Branch Galveston Texas United States 77555-0209
    74 Texas Tech University Health Science Center Lubbock Texas United States 79423
    75 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    76 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
    77 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    78 CCOP - Scott and White Hospital Temple Texas United States 76508
    79 Huntsman Cancer Institute Salt Lake City Utah United States 84132
    80 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    81 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    82 Swedish Cancer Institute Seattle Washington United States 98104
    83 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    84 CCOP - Northwest Tacoma Washington United States 98405-0986

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: William H. Isacoff, MD, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00003018
    Other Study ID Numbers:
    • CDR0000065599
    • S9700
    • U10CA032102
    First Posted:
    Apr 22, 2004
    Last Update Posted:
    Jan 3, 2013
    Last Verified:
    Jan 1, 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:
    Pancreatic Neoplasms
    Leucovorin
    Fluorouracil
    Mitomycins
    Mitomycin
    Dipyridamole
    Calcium
    Levoleucovorin

    Study Results

    No Results Posted as of Jan 3, 2013