Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Aultman Health Foundation

Status and phase

Terminated

Phase 2

Conditions

Mediastinal Neoplasms

Treatments

Drug: Intravenous Topotecan

Drug: Intravenous Docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00315211

Lung 01 (Other Identifier)

Hycamtin study #102143

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No 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