Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	no age specified	NCI	EST-1285

Objectives

I.  Compare in a randomized study the therapeutic efficacy and toxicity of PF 
(cis-platinum/5-fluorouracil) vs. MVPF 
(mitomycin-C/vincristine/cis-platinum/5-fluorouracil) in the treatment of 
advanced large bowel cancer.
II.  If activity is confirmed, determine the response rate, toxicity, and 
survival associated with each of the regimens.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable and 
histologically confirmed metastatic, residual, or recurrent adenocarcinoma of 
the colon or rectum provided there is no hope of surgical eradication and the 
patient has had no prior radiotherapy or chemotherapy.  Malignant hepatomegaly 
may be accepted as a measurable lesion if the liver contains biopsy-proven 
cancer and if the liver edge is clearly defined at least 5 cm below the costal 
margin or xiphoid process.  The liver scan (scintogram, not camera) may be 
used as an indicator only if it contains at least one clearly defined 
measurable perfusion defect of at least 5 cm in diameter.  The ECOG 
performance score must be 0 or 1 and patients must have adequate liver and 
bone marrow function and no evidence of renal disease.  Patients must have 
recovered from the effects of major surgery and be at least 2 weeks 
postoperative (3 weeks if bowel resection, anastomosis, or bypass was 
performed).  There may be no significant detectable infection, and patients 
with elevated WBC or fever may not enter until occult infection is ruled out.  
The nutritional status must be adequate, and patients must be free from severe 
nausea and frequent vomiting.  There may be no past or present other 
malignancy except for curatively treated basal or squamous cell skin carcinoma 
and in-situ carcinoma of the cervix.

Expected Enrollment

After initial entry of 20 patients per arm, 5 additional patients will be 
added for each responding patient on an arm up to a maximum of 20 additional 
patients per arm.  Accrual of the initial 20 patients per arm is anticipated 
to require about 6 months, with 3-6 months needed for entry of additional 
patients.

Outline

Randomized study.
Arm I:  2-Drug Combination Chemotherapy.  PF:  cis-Platinum, CACP, NSC-119875; 
5-Fluorouracil, 5-FU, NSC-19893.
Arm II:  4-Drug Combination Chemotherapy.  MVPF:  Mitomycin-C, MITO, 
NSC-26980; Vincristine, VCR, NSC-67574; CACP; 5-FU.

Pandya KJ, Lefkopoulou M, Petrelli NJ, et al.: Phase II study of cisplatin and 5-fluorouracil (PF) and mitomycin C, vincristine, cisplatin and 5-fluorouracil (MVPF) in patients with metastatic large bowel cancer: an Eastern Cooperative Oncology Group study (EST 1285). Oncology 66 (2): 118-25, 2004.[PUBMED Abstract]

Pandya KJ, Petrelli NJ, Leftkopoulou M, et al.: Phase II evaluation of mitomycin C (M), vincristine (V), platinum (P), and 5-fluorouracil (F) or PF in advanced large bowel cancer (ALBC): an Eastern Cooperative Oncology Group (ECOG) study. [Abstract] Proceedings of the American Society of Clinical Oncology 8: A-403, 104, 1989.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Kishan Pandya, MD, Protocol chair		Ph: 585-275-9319 Email: kishan_pandya@urmc.rochester.edu