Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

NCT00005036 | Completed Phase 3

• 7 other identifiers: NCI-2012-01847N9841SWOG-N9841NCCTG-N9841CDR0000067623ECOG-N9841U10CA025224
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for colorectal cancer.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  At least 6 months

Secondary Outcomes (5)

• Time-to-tumor progression

  Time from start of therapy to documentation of disease progression, assessed up to 3 years

• Time-to-treatment failure

  Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years

• Objective tumor response rate (CR or PR) in patients with measureable disease

  At least 4 weeks

• Toxicity and dose intensity

  Up to 3 years

• Quality of life

  Up to 3 years

Study Arms (2)

Arm I (irinotecan)

EXPERIMENTAL

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

Drug: irinotecan hydrochloride; Procedure: quality-of-life assessment

Arm II (oxalipatin, fluorouracil, leucovorin calcium)

EXPERIMENTAL

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.

Drug: oxaliplatin; Drug: leucovorin calcium; Drug: fluorouracil; Procedure: quality-of-life assessment

Interventions

irinotecan hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E

Arm I (irinotecan)

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Arm II (oxalipatin, fluorouracil, leucovorin calcium)

leucovorin calcium DRUG

Given IV

Also known as: CF, CFR, LV

Arm II (oxalipatin, fluorouracil, leucovorin calcium)

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Arm II (oxalipatin, fluorouracil, leucovorin calcium)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (irinotecan); Arm II (oxalipatin, fluorouracil, leucovorin calcium)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• SWOG Cancer Research Network: collaborator
• Eastern Cooperative Oncology Group: collaborator

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Irinotecan; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Henry Pitot

  North Central Cancer Treatment Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: January 27, 2003
• Study Start: November 1, 1999
• Primary Completion: December 1, 2006
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)