Combination Therapy With Oral 9-Nitrocamptothecin & Oral Etoposide
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|ClinicalTrials.gov Identifier: NCT00006047|
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : September 26, 2012
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness of nitrocamptothecin plus etoposide in treating patients who have advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: Oral Etoposide Drug: Oral 9-Nitrocamptothecin||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and safety of nitrocamptothecin when administered with etoposide in patients with advanced solid tumors. II. Determine the changes in expression and activity of topoisomerase I and II which occur during administration of this treatment regimen in these patients. III. Determine the plasma pharmacokinetics of this treatment regimen in these patients. IV. Compare the hematologic and nonhematologic toxicities with this treatment regimen in patients 70 years of age and older versus patients younger than 70 years of age.
OUTLINE: This is a dose escalation study of nitrocamptothecin. Patients receive oral nitrocamptothecin on days 1-3 and oral etoposide on days 4-5 each week. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of nitrocamptothecin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 4 weeks until toxicities resolve.
PROJECTED ACCRUAL: Approximately 40-60 patients will be accrued for this study over 18 to 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Combination Therapy With Oral 9-Nitrocamptothecin and Oral Etoposide|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||February 2003|
|Actual Study Completion Date :||February 2003|
Experimental: Combination Therapy
Combination Therapy with Oral 9-Nitrocamptothecin & Oral Etoposide. Patients receive oral nitrocamptothecin on days 1-3 and oral etoposide on days 4-5 each week. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: Oral Etoposide
Drug: Oral 9-Nitrocamptothecin
- Maximum Tolerated Dose (MTD) [ Time Frame: 3 years ]Determine the MTD of nitrocamptothecin. Cohorts of 3-6 patients receive escalating doses of nitrocamptothecin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
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): NCT00006047
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Principal Investigator:||Daniel M. Sullivan, M.D.||H. Lee Moffitt Cancer Center and Research Institute|