Recruiting
Phase 2

Carboplatin, Gemcitabine & Bevacizumab

Sponsor:

St. John Providence Health System

Code:

NCT00150657

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

bevacizumab

carboplatin

gemcitabine

Study Details

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

Study ID

NCT00150657

Start date

Nov, 2004

Status verified date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

45 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

bevacizumab

carboplatin

gemcitabine

Primary outcome measure

  • time to progression [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Michael J Kraut, MD

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

Jaswinder Grewal, PhD

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

Locations

Providence Cancer Institute

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Michael J Kraut, MD

248-849-8155mkraut@providence-hospital.org

Howard Terebelo, DO

248-552-0620

Principal Investigator:

Michael J Kraut, MD

More Information

Sponsor

St. John Providence Health System

Last update posted

Nov 29, 2005

Last verified

Sep, 2005

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. John Providence Health System on 2005-11-29.