Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00150657
• Other study ID #: AVF3121s
• Status: Recruiting
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: November 28, 2005
• Start date: November 2004

Study information

• Verified date: September 2005
• Source: St. John Providence Health System
• Contact: Michael J Kraut, MD
• Phone: 248-849-3541
• Email: mkraut[@]providence-hospital.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

• this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added

• the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen)

• all patients receive all three drugs; there is no placebo

Description:

• Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible.

• Patients with brain metastases, squamous histology, or hemoptysis are excluded.

• All patients must give informed consent.

• Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy

• Stage IV disease or stage IIIB with a malignant pleural effusion

• measurable or evaluable disease

• Performance status 0 or 1 (ECOG)

• adequate renal, hepatic, and bone marrow function

• adequate recovery from previous surgery or radiotherapy

• informed consent

Exclusion Criteria:

• brain metastases

• squamous (epidermoid) histology

• hemoptysis

• central airway disease

• Pancoast tumors

• previous chemotherapy or biologic therapy for lung cancer

• prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS

• pregnant or nursing women

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• bevacizumab

• carboplatin

• gemcitabine

Locations

Country	Name	City	State
United States	Providence Cancer Institute	Southfield	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
St. John Providence Health System	Eli Lilly and Company, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression
Secondary	response rate
Secondary	median survival
Secondary	one year survival
Secondary	two year survival
Secondary	toxicity