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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Small Cell Lung

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

median time to progression

Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 90

NCT ID:

NCT00294931

Start Date:

February 2006

Completion Date:

January 2009

Related Keywords:

  • Carcinoma, Small Cell Lung
  • Lung Cancer, Small Cell
  • Extensive
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell

Name

Location
Florida Cancer Specialists Fort Myers, Florida  33901
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Oncology Hematology Care Cincinnati, Ohio  45242
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404