Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
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ClinicalTrials.gov Identifier: NCT00150657 |
Recruitment Status : Unknown
Verified September 2005 by St. John Providence Health System.
Recruitment status was: Recruiting
First Posted : September 8, 2005
Last Update Posted : November 29, 2005
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- 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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Lung Cancer | Drug: bevacizumab Drug: carboplatin Drug: gemcitabine | Phase 2 |
- 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
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 45 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer |
Study Start Date : | November 2004 |

- time to progression
- response rate
- median survival
- one year survival
- two year survival
- toxicity

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150657
Contact: Michael J Kraut, MD | 248-849-3541 | mkraut@providence-hospital.org | |
Contact: Jaswinder Grewal, PhD | 248-849-5337 | jgrewal@providence-hospital.org |
United States, Michigan | |
Providence Cancer Institute | Recruiting |
Southfield, Michigan, United States, 48075 | |
Contact: Michael J Kraut, MD 248-849-8155 mkraut@providence-hospital.org | |
Contact: Howard Terebelo, DO 248-552-0620 | |
Principal Investigator: Michael J Kraut, MD | |
Sub-Investigator: Howard Terebelo, DO | |
Sub-Investigator: Anibal Drelichman, MD | |
Sub-Investigator: Robert Bloom, MD | |
Sub-Investigator: Lyle Goldman, MD | |
Sub-Investigator: Judie Goodman, DO |
Principal Investigator: | Michael J Kraut, MD | Providence Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00150657 |
Other Study ID Numbers: |
AVF3121s |
First Posted: | September 8, 2005 Key Record Dates |
Last Update Posted: | November 29, 2005 |
Last Verified: | September 2005 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Bevacizumab Carboplatin Antineoplastic Agents, Immunological |
Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |