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NCT Number: NCT00305942

Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northeast Alabama Regional Medical Center, Anniston, Alabama, United States

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About this study

Eligible patients will receive treatment with carboplatin and topotecan.

Topotecan 4mg/m2 IV on days 1, 8.

Carboplatin AUC=5 IV day 1 only .

  • Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have confirmed small cell lung cancer with extensive stage disease. This includes patients with stage IIIB and IV disease.
  • Patients with small cell histology are eligible. Large neuroendocrine or mixed small cell and non-small cell histology are not eligible.
  • Patients must have measurable or evaluable disease.
  • ECOG performance status 0 or 1.
  • Patients must have adequate bone marrow, liver and kidney function
  • The patients may have had no previous chemotherapy.
  • Patients must be able to understand the nature of the study and give written informed consent.

Exclusion criteria

  • Patients with limited stage disease. This includes IA, IB, IIA, IIB, and IIIA.
  • Age < 18 years old.
  • History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma or stage A/B prostate cancer.
  • Female patients who are pregnant or are breast feeding
  • History of acute myocardial infarction or stroke within 6 months.
  • Uncontrolled hypertension, unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease.
  • Patients who have received other investigational drugs within 28 days.
  • Patients with CNS involvement (brain or meningeal). The single exception to this is the patient previously treated for brain metastases with radiation therapy, or surgical excision who has no evidence of active residual metastases on brain MRI at the time of study entry.
  • Patients with large neuroendocrine tumor or mixed small cell and non-small cell histology

Treatment and study plan

Topotecan

Drug

Topotecan 4mg/m2 IV on days 1, 8.

Other names: Hycamtin

carboplatin

Drug

Carboplatin AUC=5 IV day 1 only .

Other names: 41575-94-4

Primary outcomes

  1. Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

    Time frame: 18 months

    Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.

    The final response category assigned represented the best response obtained during treatment.

Secondary outcomes

  1. Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

    Time frame: 18 months

    Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.

  2. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Time frame: 18 months

    Overall survival was measured from the date of study entry until the date of death.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Mar 22, 2006
Registry last updated
Jan 31, 2013

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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