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NCT Number: NCT00294931

Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer

This multicenter phase II trial is designed to study the unique combination of chemotherapy (irinotecan./carboplatin) and bevacizumab in the extensive-stage setting. This clinical setting seems ideal for evaluation of the role of bevacizumab in delaying progression and prolonging survival.

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Key information

Conditions

Carcinoma, Small Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site 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

Florida Cancer Specialists, Fort Myers, Florida, United States

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About this study

Eligible patients will receive 6 courses of irinotecan, carboplatin, and bevacizumab. The interval between chemotherapy courses will be 28 days. If after 6 courses of treatment, patient's response is a CR/PR/SD they will continue on Bevacizumab until tumor progression or up to 6 cycles (6 months) total.

Treatment sequence:

  • Irinotecan 60mg/m2 on days 1, 8, and 15
  • Carboplatin AUC=4 day 1 only
  • Bevacizumab 10 mg/kg days 1 and 15

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed small cell lung cancer,extensive stage disease.
  • Measurable or evaluable disease
  • No previous chemotherapy
  • Able to perform activities of daily living with minimal assistance
  • Adequate hematological, live and kidney function
  • Provide written informed consent

Exclusion criteria

  • Limited stage disease
  • PEG or G tubes
  • Hemoptysis
  • Abdominal fistula, perforation, or abscess within the previous 6 months
  • Women who are pregnant or lactating
  • Proteinuria
  • Serious nonhealing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • Uncontrolled or serious cardiovascular disease
  • Uncontrolled brain metastasis
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days; Fine needle aspiration within 7 days
  • Patients requiring full-dose anticoagulation must be on a stable dosing schedule prior to enrollment

Treatment and study plan

Irinotecan

Drug

carboplatin

Drug

Bevacizumab

Drug

Primary outcomes

  1. median time to progression

Secondary outcomes

  1. overall toxicity

  2. overall response rate

  3. duration of response

  4. overall survival

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

A Phase II Trial of Irinotecan, Carboplatin, Bevacizumab 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 22, 2006
Registry last updated
Jun 28, 2010

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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