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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

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Trial Information

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


PRIMARY OBJECTIVES:

I. Determine whether in advanced colorectal carcinoma patients who have been previously
treated with 5-FU, the overall survival of patients treated with OXAL + 5-FU + CF followed
by CPT-11 is equivalent to the survival of patients treated with CPT-11 followed by OXAL +
5-FU + CF.

SECONDARY OBJECTIVES:

I. Evaluation of time to tumor progression, time to treatment failure, toxicity of
treatment, and overall response rate in patients treated with these two regimens.

II. To compare quality-of-life measurements patients treated with these two regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
performance status (ECOG 0-1 vs 2), primary indicator lesion (hepatic vs pulmonary vs
other), age (less than 65 vs at least 65 years), alkaline phosphatase (less than 2 vs at
least 2 times ULN), fluorouracil failure (adjuvant vs metastatic), and membership
(intergroup vs expanded participation project). Patients are randomized to one of two
treatment arms.

ARM I: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3
weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2
hours on days 1 and 2, and fluorouracil IV bolus followed by IV infusion over 22 hours on
days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or
unacceptable toxicity.

Patients who experience progression or toxicity on the initial regimen may crossover to the
other regimen. At least 3 weeks must elapse between regimens.

Quality of life is assessed at baseline, prior to each chemotherapy course, at crossover,
and at the end of the study.

Patients are followed every 6 months for 3 years or until death.


Inclusion Criteria:



- Histologically or cytologically confirmed locally advanced, locally recurrent,or
metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy

- Progressive disease following:

- One prior fluorouracil based chemotherapy regimen for metastatic disease

- Failure during or within 6 months after fluorouracil based adjuvant therapy

- Measurable or evaluable disease

- No CNS metastases or carcinomatous meningitis

- Performance status - ECOG 0-2

- At least 12 weeks

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

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

- Hemoglobin at least 9 g/dL (transfusion allowed)

- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 5 times ULN

- Creatinine no greater than 1.5 times ULN

- No uncontrolled high blood pressure

- No unstable angina

- No symptomatic congestive heart failure

- No myocardial infarction with the past 6 months

- No serious uncontrolled cardiac arrhythmias

- No New York Heart Association class III or IV heart disease

- No pleural effusion or ascites that cause respiratory compromise (e.g., dyspnea grade
2 or greater)

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

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Fluent in English

- No active or uncontrolled infection

- No other prior malignancy within the past 5 years, except:

- Adequately treated basal or squamous cell skin cancer

- Adequately treated noninvasive carcinomas

- No sensory neuropathy grade 2 or greater

- No uncontrolled colonic or small bowel disorders (greater than 3 loose stools daily)

- No concurrent sargramostim (GM-CSF)

- At least 4 weeks since prior chemotherapy and recovered

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

- No prior irinotecan or other camptothecin derivative (e.g., topotecan)

- No prior oxaliplatin

- No other concurrent investigational chemotherapy agents

- At least 4 weeks since prior major radiotherapy

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

- At least 4 weeks since prior major surgery and recovered

- At least 2 weeks since prior minor surgery and recovered

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

The primary analysis for this trial will be based on a one-sided Generalized Wilcoxon test.

Outcome Time Frame:

At least 6 months

Safety Issue:

No

Principal Investigator

Henry Pitot

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01847

NCT ID:

NCT00005036

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Mucinous Adenocarcinoma of the Colon
  • Mucinous Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Signet Ring Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage IIIA Colon Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Cystadenocarcinoma
  • Colorectal Neoplasms

Name

Location

North Central Cancer Treatment GroupRochester, Minnesota  55905