Nitrocamptothecin in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005873|
Recruitment Status : Completed
First Posted : April 13, 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 locally recurrent or metastatic breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: rubitecan||Phase 2|
OBJECTIVES: I. Assess the toxicity and efficacy of nitrocamptothecin in patients with locally recurrent or metastatic breast cancer. II. Determine the duration of response and time to treatment failure in these patients with this treatment regimen. III. Correlate serum levels of nitrocamptothecin and its lactone metabolite with response and toxicity in these patients. IV. Correlate topoisomerase I and II levels with toxicity and response in these patients.
OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for 8 weeks. Patients achieving complete or partial response or stable disease continue therapy in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 8-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Relapsed Metastatic Breast Cancer|
|Study Start Date :||September 1999|
|Study Completion Date :||April 2004|
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): NCT00005873
|United States, California|
|Dublin, California, United States, 94568|
|Study Chair:||Show-Li Sun, MD||Astex Pharmaceuticals|