Combination Chemotherapy in Treating Patients With Colorectal Cancer

NCT00006103 | Completed Phase 3

• 5 other identifiers: CALGB-9864U10CA031946CLB-9864E-C9864CDR0000068113
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if the effectiveness of irinotecan combined with fluorouracil in treating colorectal cancer varies depending on the patient's racial background. PURPOSE: Phase III trial to study the effectiveness of irinotecan combined with fluorouracil in treating patients from different racial backgrounds who have colorectal cancer that is advanced, recurrent, metastatic or has not responded to treatment with fluorouracil.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

• overall survival

  Up to 10 years

Study Arms (1)

irinotecan + leucovorin + fluorouracil

EXPERIMENTAL

Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for a total of 5 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

Interventions

fluorouracil DRUG

irinotecan + leucovorin + fluorouracil

irinotecan hydrochloride DRUG

irinotecan + leucovorin + fluorouracil

leucovorin calcium DRUG

irinotecan + leucovorin + fluorouracil

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Metastatic, locally advanced, or recurrent disease * Patients must have at least 2 generations (parents and grandparents) who belong to one of the following racial groups: * Asian or Pacific Islander (e.g., China, Japan, Korea, the Philippine Islands, or Samoa) * Black (originating from the black racial groups of Africa) * Hispanic (originating from Mexico, Puerto Rico, Cuba, Central or South America, or other Spanish culture) * White (originating from the peoples of Europe, North Africa, or the Middle East) * No patients with parents or grandparents of mixed race or race other than that of the patient PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * CTC 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior adjuvant fluorouracil allowed if relapse occurred at least 6 months after completion of fluorouracil * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior irinotecan * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormones except steroids for adrenal failure, hormones for nondisease related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic * No concurrent prednisone Radiotherapy: * At least 4 weeks since prior radiotherapy (except to bone or soft tissue involving less than 25% of bone marrow) * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No concurrent phenobarbital, valproate, or cyclosporine * None of the following concurrently during first course of therapy: * Macrolide antibiotics (e.g., azithromycin, erythromycin, clarithromycin, troleandomycin, dapsone) * Azole antibiotics (e.g., fuconazole, miconazole, itraconazole, ketoconazole) * Triazobenzodiazepines (e.g., alprazolam, midazolam, triazolam) * Antidepressants (e.g., fluoxetine, setraline hydrochloride, fluoxamine, nefazodone hydrochloride) * Quinolone antimicrobials (e.g., ciprofloxacin, ofloxacin) * Imidazole antibiotics (e.g., clotrimazole) * Anti-ulcer medications (e.g., omeprazole, lansoprazole) * Ethinyl estradiol * Diltiazem * Cimetidine hydrochloride * Cisapride * Terfenadine * Rifampin * Glucocorticoids * Antiepileptics * Grapefruit juice

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Fluorouracil; Irinotecan; Leucovorin

Condition Hierarchy (Ancestors)

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)

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

Study Officials

• Brian Leyland-Jones, MD

  McGill Cancer Centre at McGill University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: September 3, 2003
• Study Start: July 1, 2000
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: July 6, 2016

Record last verified: 2016-07