Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Sponsor

Aultman Health Foundation (Other)

Overall Status

Terminated

CT.gov ID

NCT00315211

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arm

36.2

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are:

To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

Condition or Disease	Intervention/Treatment	Phase
Mediastinal Neoplasms	Drug: Intravenous Topotecan Drug: Intravenous Docetaxel	Phase 2

Detailed Description

The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Nov 8, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm A Weekly intravenous topotecan with intravenous docetaxel	Drug: Intravenous Topotecan Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days Other Names: Hycamtin Drug: Intravenous Docetaxel Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle Other Names: Taxotere

Arm

Intervention/Treatment

Other: Arm A

Weekly intravenous topotecan with intravenous docetaxel

Drug: Intravenous Topotecan

Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days

Other Names:

Hycamtin

Drug: Intravenous Docetaxel

Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle

Other Names:

Taxotere

Outcome Measures

Primary Outcome Measures

To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel [3 years]
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Recurred greater than 90 days after initial treatment
At least 1 measurable lesion
Only 1 prior chemotherapy
Must be over 18 years of age
ECOG performance status of 0 - 2
Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

No prior use of topotecan, docetaxel, or irinotecan
No symptomatic brain metastases
History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
No prior investigational agents within 1 month prior
Lung cancer of mixed histology
Known uncontrolled seizure disorders