Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00315211

Enrollment

Registered

2006-04-18

Start date

2004-11-30

Completion date

2007-11-08

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mediastinal Neoplasms

Keywords

Small Cell Lung Cancer Recurrent

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.

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.

Interventions

DRUGIntravenous Topotecan

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

DRUGIntravenous Docetaxel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026