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Phase II Studies in Patients With Metastatic Colorectal Carcinoma Previously Treated With Oxaliplatin (OXAL) or a Combination of Irinotecan (CPT-11) and Oxal

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Phase II Studies in Patients With Metastatic Colorectal Carcinoma Previously Treated With Oxaliplatin (OXAL) or a Combination of Irinotecan (CPT-11) and Oxal


- Determine the tumor response rate in patients receiving irinotecan or fluorouracil and
leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin
with or without irinotecan.

- Determine the time to tumor progression, time to treatment failure, and overall
survival of patients treated with these regimens.

- Determine the toxic effects of these regimens in these patients.

- Evaluate the quality of life of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy).
Patients are assigned to one of two treatment groups.

- Group I (prior oxaliplatin-based chemotherapy): Patients receive irinotecan IV over 90
minutes on day 1. Treatment repeats every 3 weeks.

- Group II (prior irinotecan and oxaliplatin combination chemotherapy): Patients receive
leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2.
Treatment repeats every 2 weeks.

- Both groups: Treatment continues in the absence of disease progression or unacceptable
toxicity. Patients with a confirmed complete response for 2 consecutive courses may
discontinue treatment at investigator's discretion.

Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and
then after the last course of treatment.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 40-96 patients (20-48 per arm) will be accrued for this study
within 1-2 years.

Inclusion Criteria


- Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not
amenable to radiotherapy with curative intent

- Progressive disease after one of the following prior treatments for metastatic

- Oxaliplatin-based chemotherapy

- Irinotecan and oxaliplatin combination chemotherapy

- At least 1 measurable lesion

- At least 20 mm in at least one dimension

- No known CNS metastases or carcinomatous meningitis



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN)

- AST no greater than 5 times ULN


- Creatinine no greater than 1.5 times ULN


- No unstable angina

- No symptomatic congestive heart failure

- No serious uncontrolled cardiac arrhythmia


- No active or uncontrolled infection

- No evidence of other serious illness

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or noninvasive carcinomas

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- No concurrent sargramostim (GM-CSF)


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- No more than 1 prior chemotherapy regimen for advanced colorectal cancer

- Prior adjuvant chemotherapy allowed

Endocrine therapy:

- Not specified


- See Disease Characteristics

- No prior radiotherapy to more than 25% of bone marrow


- See Disease Characteristics

- At least 4 weeks since prior major surgery

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Principal Investigator

Henry C. Pitot, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
Mayo Clinic Jacksonville, Florida  32224