Gemcitabine in Treating Patients With Advanced Colorectal Cancer

NCT00007943 | Completed Phase 2 FDA Drug

• 3 other identifiers: REBACDR0000068355CCCWFU-59198NCI-914
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 gemcitabine in treating patients who have advanced colorectal cancer.

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

Interventions

gemcitabine hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer that has failed at least 1 prior course of fluoropyrimidine-based chemotherapy Measurable and/or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 2.5 times upper limit of normal (ULN) * ALT and/or AST no greater than 3 times ULN (no greater than 10 times ULN if * secondary to hepatic involvement by tumor Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No history of cardiac arrhythmias requiring chronic treatment beyond an * acute event (e.g., arrhythmias during severe electrolyte abnormalities * allowed) * No active cardiac disease requiring treatment other than hypertension, * stable angina, or chronic valvular disease Other: * No other malignancy within the past 5 years except curatively treated * (including surgically cured) cancer * No serious medical or psychiatric illness that would preclude study * No active uncontrolled bacterial, fungal, or viral infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No more than 3 prior chemotherapy regimens * Must have 1 prior fluorouracil-based regimen and 1 other cytotoxic agent * (e.g., irinotecan) * More than 4 weeks since prior chemotherapy * Prior gemcitabine allowed * No other concurrent antineoplastic therapy Endocrine therapy: * Not specified Radiotherapy: * More than 4 weeks since prior radiotherapy Surgery: * More than 4 weeks since prior surgery

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Gemcitabine

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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Paul D. Savage, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2001
• First Posted: April 13, 2004
• Study Start: September 1, 2000
• Primary Completion: February 27, 2001
• Study Completion: February 27, 2001
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

US (1)