Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294190

Enrollment

Registered

2006-02-20

Start date

2006-02-28

Completion date

2009-07-31

Last updated

2012-12-10

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

Conditions

Carcinoma, Small Cell, Small Cell Lung Cancer

Keywords

Lung Cancer, Extensive stage, Small Cell Lung Cancer

Brief summary

This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.

Detailed description

All patients will receive weekly topotecan. Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)

Interventions

DRUGTopotecan

Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen * Measurable or evaluable disease * Able to perform activities of daily living with minimal assistance * Adequate bone marrow, liver and kidney function * May have received no more than 3 previous courses of radiation therapy * Give written informed consent prior to study entry

Exclusion criteria

* Patients with limited stage disease * History of a prior malignancy within three years * Female patients who are pregnant or are breast feeding * Significant history of uncontrolled cardiac disease * Myocardial infarction or stroke within six months * Symptomatic peripheral vascular disease * CNS involvement * Serious active infection or underlying medical condition

Design outcomes

Primary

Measure	Time frame
Overall response rate	18 months

Secondary

Measure	Time frame
time to progression	18 months
duration of response	18 months
overall survival	18 months
overall toxicity	18 months

Countries

United States

Outcome results

None listed

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