Combination Therapy With Oral 9-Nitrocamptothecin & Oral Etoposide

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: Oral Etoposide; Drug: Oral 9-Nitrocamptothecin

• Registration Number: NCT00006047
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2000-06
• Study First Submitted: 2000-07-05
• Primary Completion: 2003-02
• Study Completion: 2003-02
• Study First Submitted QC: 2004-02-11
• Study First Posted: 2004-02-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination Therapy	Oral Etoposide	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.
Combination Therapy	Oral 9-Nitrocamptothecin	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.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	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.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States