Nitrocamptothecin in Treating Patients With Advanced or Recurrent Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00005877|
Recruitment Status : Unknown
Verified April 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 12, 2004
Last Update Posted : December 4, 2013
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 nitrocamptothecin in treating patients who have advanced or recurrent colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: rubitecan||Phase 2|
OBJECTIVES: I. Determine the objective response rate, overall survival, and time to disease progression after maximal response in patients with advanced or metastatic colorectal cancer treated with oral nitrocamptothecin. II. Determine the safety, toxicity, and pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral nitrocamptothecin on days 1-5. Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of course 8 may receive additional courses. Patients are followed every 3 months for 1 year or until death.
PROJECTED ACCRUAL: Approximately 14-45 patients will be accrued for this study over less than 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II and Pharmacokinetic Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Advanced Colorectal Cancer Who Have Failed Previous 5-FU Based Chemotherapy|
|Study Start Date :||September 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005877
|United States, California|
|Dublin, California, United States, 94568|
|Study Chair:||Show-Li Sun, MD||Astex Pharmaceuticals|