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A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma

Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma


- Compare the overall survival of patients with metastatic colorectal cancer treated with
irinotecan with or without oxaliplatin.

- Compare the response rate, time to tumor-related worsening of symptoms, time to disease
progression, onset and duration of responses, and duration of disease stabilization in
these patients treated with these regimens.

- Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs
involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of
normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant
vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment

- Arm I: Patients receive irinotecan IV over 90 minutes on day 1.

- Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over
30 minutes on day 1.

Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months

PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study
within 18 months.

Inclusion Criteria


- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum

- Metastatic or recurrent disease that is not amenable to potentially curative

- Progressive or recurrent disease during or after 1, and only 1, regimen of
fluorouracil with or without leucovorin calcium or during or within 6 months after
adjuvant chemotherapy with fluorouracil and leucovorin calcium



- 18 and over

Performance status:

- Karnofsky 50-100%

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

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


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT/SGPT no greater than 2 times ULN (no greater than 5 times ULN if liver
metastases present)

- Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if
liver metastases present)


- Creatinine no greater than 1.5 times ULN


- No unstable angina

- No New York Heart Association class III or IV congestive heart failure

- No serious cardiac arrhythmia

- No history of cardiac toxicity from fluorouracil/leucovorin calcium

- No myocardial infarction within past 6 months


- No interstitial pneumonia or extensive and symptomatic fibrosis of the lung


- No uncontrolled predisposing colonic or small bowel disorder

- No prior chronic enteropathy, chronic diarrhea, or unresolved bowel

- No diabetes

- No active infection

- No known current peripheral neuropathy

- No concurrent active cancer except curatively treated nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No intolerance of appropriate antiemetics

- No history of anaphylaxis or potential intolerance to atropine sulfate or loperamide

- Not pregnant or nursing

- Negative pregnancy test


Biologic therapy:

- Not specified


- See Disease Characteristics

- At least 3 weeks since prior chemotherapy

- No prior irinotecan or oxaliplatin

- No other prior chemotherapy agents except fluorouracil with or without leucovorin
calcium as first-line therapy for metastatic disease or in the adjuvant setting

Endocrine therapy:

- Not specified


- Prior radiotherapy to non-target lesions allowed

- No prior radiotherapy to target lesions unless disease progression is documented
within the radiation port

- At least 3 weeks since prior radiotherapy


- At least 4 weeks since prior major surgical procedure and recovered

- Prior surgery for primary tumor or metastasis allowed


- At least 30 days since prior investigational drug

- No concurrent investigational agents

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Daniel G. Haller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Federal Government

Study ID:




Start Date:

December 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms



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