| Clinical
Trial: |
N9841
- Advanced Colorectal Carcinoma |
| Governing Group: |
Southwest Oncology
Group |
| Title: |
"A Randomized
Phase III Equivalence Trial of Irinotecan (CPT-11) versus Oxaliplatin
(OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced
Colorectal Carcinoma Previously Treated with 5-FU." |
Eligibility:
- Known locally advanced, locally recurrent or metastasized colorectal
adenocarcinoma not curable by surgery or amenable to radiation
with curative intent.
- Progressive disease following one prior 5-FU based regimen
for metastasized disease or failure during or within six (6) months
of 5-FU based adjuvant therapy.
- Histologically or cytologically confirmed adenocarcinoma of
the colon or rectum.
- Measurable or evaluable disease.
- ECOG performance status 0-2.
- Greater than or equal to four (4) weeks from prior chemotherapy.
- Adequate hematologic, renal and hepatic function.
- Patients of childbearing potential must agree to use effective
method of contraception.
- Patients must be able and willing to complete the QOL assessments
in English.
- Patients must not have more than one prior chemotherapy regimen
for advanced colorectal cancer, previous CPT-11 or other camptothecin
derivative.
- No previous oxaliplatin, prior radiation greater than 25% of
bone marrow.
- No active or uncontrolled infection.
- No uncontrolled high blood pressure, unstable angina.
- No symptomatic congestive heart failure.
- No myocardial infarction less than or equal to six (6) months
prior to randomization.
- No serious uncontrolled cardiac arrhythmia, New York Heart
Association classification III or IV.
- Patients must not be pregnant or nursing.
- Patients must not have prior malignancy, known CNS metastasis
or carcinomatous meningitis, interstitial pneumonia or extensive
and symptomatic interstitial fibrosis of the lung.
- No pleural effusion or ascites which cause respiratory compromise.
- No pre-existing neuropathy or predisposing colonic or small
bowel disorders.
|
