Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer

NCT00002933 | Completed Phase 2 DMC

• 1 other identifier: CWRU1296
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent colorectal cancer.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effectiveness of irinotecan in treating patients who have metastatic or recurrent colorectal cancer.

  Starting dose weekly for 4 weeks followed by 2 weeks of rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumor status is reassessed every 12 weeks during study.

Interventions

irinotecan hydrochloride DRUG

Irinotecan IV at a starting dose weekly for 4 weeks followed by 2 weeks of rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumor status is reassessed every 12 weeks during study. Patients attaining a complete response may receive additional courses of treatment. Patients are followed until death.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or recurrent adenocarcinoma of the colon or rectum that is incurable by surgery or radiation therapy A metastatic lesion in the liver or lung should be evaluated for definitive surgical treatment before being considered for this study Measurable disease required Elevated CEA, hepatomegaly ascites, pleural effusion, positive nuclear scan or bone scan, or poorly defined pelvic or abdominal mass are NOT considered measurable disease Must have measurable disease outside the radiation port or progression of disease within a previously radiated area Must be eligible for a biopsy of a malignant lesion No ascites that are detectable on physical exam No brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 4,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.2 mg/dL SGOT less than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL or Creatinine clearance at least 60 mL/min Other: No history of any other malignancy except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix No active infection or other serious medical conditions deemed unacceptable Negative pregnancy test Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced disease Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy Surgery: At least 3 weeks since any surgical procedure

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Veterans Affairs Medical Center - Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Irinotecan

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)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• James KV Willson, MD

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 12, 2004
• Study Start: September 1, 1996
• Primary Completion: July 1, 2000
• Study Completion: January 1, 2001
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

US (2)