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Phase I Study of Weekly Topotecan in Combination With Sorafenib in Treatment of Relapsed Small Cell Lung Cancer

NCT00466232 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-12-16

No results posted yet for this study

Summary

The primary objective of this study is to determine the maximum tolerated dose of sorafenib up to the full active dose when combined with standard weekly dosing of topotecan in patients with recurrent small cell lung cancer and to characterize the toxicities associated with the combination of topotecan and sorafenib in this patient population

Conditions

Interventions

DRUG

Topotecan

4 mg/m2 IV on day 1, 8, 15. Repeat every 28 days.

DRUG

Sorafenib

Dose escalation study at 3 dose levels: 200 mg po daily, 200 mg po bid, 400 mg po bid.

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Joseph Leach, MD · HealthPartners Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00466232 on ClinicalTrials.gov