Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/22/2018 |
| Start Date: | November 2004 |
| End Date: | November 8, 2007 |
Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
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.
- 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.
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.
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.
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
We found this trial at
1
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