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Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by St. John Providence Health System.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
St. John Providence Health System
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by:
St. John Providence Health System
ClinicalTrials.gov Identifier:
NCT00150657
First received: September 6, 2005
Last updated: November 28, 2005
Last verified: September 2005
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Purpose
- 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 | Intervention | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer | Drug: bevacizumab Drug: carboplatin Drug: gemcitabine | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by St. John Providence Health System:
Primary Outcome Measures:
- time to progression
Secondary Outcome Measures:
- response rate
- median survival
- one year survival
- two year survival
- toxicity
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2004 |
- 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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150657
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150657
Contacts
| Contact: Michael J Kraut, MD | 248-849-3541 | mkraut@providence-hospital.org | |
| Contact: Jaswinder Grewal, PhD | 248-849-5337 | jgrewal@providence-hospital.org |
Locations
| 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 | |
Sponsors and Collaborators
St. John Providence Health System
Genentech, Inc.
Eli Lilly and Company
Investigators
| Principal Investigator: | Michael J Kraut, MD | Providence Cancer Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00150657 History of Changes |
| Other Study ID Numbers: |
AVF3121s |
| Study First Received: | September 6, 2005 |
| Last Updated: | November 28, 2005 |
Additional relevant MeSH terms:
|
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 Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 26, 2017