Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

NCT00150657 | Unknown Phase 2

• 1 other identifier: AVF3121s
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• time to progression

Secondary Outcomes (5)

• response rate

• median survival

• one year survival

• two year survival

• toxicity

Interventions

bevacizumab DRUG

carboplatin DRUG

gemcitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. John Providence Health System: lead
• Genentech, Inc.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Providence Cancer Institute

Southfield, Michigan, 48075, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Michael J Kraut, MD

  Providence Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Kraut, MD

CONTACT

248-849-3541; mkraut@providence-hospital.org

Jaswinder Grewal, PhD

CONTACT

248-849-5337; jgrewal@providence-hospital.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: November 1, 2004
• Last Updated: November 29, 2005

Record last verified: 2005-09

Locations

US (1)