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NCT Number: NCT00294190

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

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Small Cell Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northeast Arkansas Clinic, Jonesboro, Arkansas, United States

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About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topotecan

Drug

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

Other names: Hycamtin

Primary outcomes

  1. Overall response rate

    Time frame: 18 months

Secondary outcomes

  1. overall toxicity

    Time frame: 18 months

  2. time to progression

    Time frame: 18 months

  3. duration of response

    Time frame: 18 months

  4. overall survival

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Feb 20, 2006
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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