Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00005036
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 3
Start date November 1999

See also
  Status Clinical Trial Phase
Completed NCT01987726 - Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
Active, not recruiting NCT00826540 - Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT00025337 - Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Phase 3
Recruiting NCT04642924 - SGM-101 in Locally Advanced and Recurrent Rectal Cancer Phase 2/Phase 3
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01217450 - Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors Phase 1
Completed NCT01191684 - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT01238965 - Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy Phase 1
Terminated NCT01285102 - Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer Phase 1
Completed NCT01037790 - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Phase 2
Completed NCT00551421 - Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer Phase 1/Phase 2
Completed NCT00407654 - VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer Phase 2
Completed NCT00091182 - Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment Phase 2
Terminated NCT00052585 - Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer Phase 2
Completed NCT00023933 - Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer Phase 1
Not yet recruiting NCT05076305 - PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting
Completed NCT01740648 - Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer Phase 1
Terminated NCT00397878 - AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer Phase 2
Completed NCT00100841 - Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer Phase 2