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A Study to Assess the Effectiveness of the Combination of Carboplatin, Paclitaxel, Bevacizumab and Combretastatin (CA4P) in Patients With Chemotherapy Naïve Lung Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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OXC401-216
NCT00653939
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Trial Description
Summary The purpose of this study is to determine the safety, tolerability and efficacy of combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve non-small cell lung cancer (NSCLC). This is a randomized parallel arm study. All participants will receive carboplatin, paclitaxel and bevacizumab, and half will additionally receive CA4P. Patients who complete the first 6 cycles of therapy and have not experienced disease progression will receive maintenance therapy with bevacizumab alone or with bevacizumab plus CA4P. The rationale for this study is the potential additive or synergistic actions of vascular disrupting agents like CA4P with anti-angiogenic agents like bevacizumab. Eligibility Criteria Inclusion Criteria: - Pathologically confirmed Stage IIIB NSCLC with malignant pleural effusion, or Stage IV disease
- Measurable disease on CT scan (by the RECIST criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 (which means able to independently care for self and to perform light work) .
- Adequate liver and kidney function
- Subjects or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
Exclusion Criteria: - Predominant Squamous Cell NSCLC histology.
- History of treatment for NSCLC with chemotherapy, biological therapy, immunotherapy (surgery or radiation therapy are accepted)
- Brain (CNS) metastasis by head CT scan or MRI
- Subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasia; or localized prostate cancer with a current prostate specific antigen (PSA) of < 4.0 mg/dL. Subjects with other curatively treated malignancies who have no evidence of metastatic disease and >2 year disease free interval may be entered after discussion with the Medical Monitor.
- History of bleeding disorders, particularly coughing up ≥ ½ teaspoon bright red blood during the last 3 months
- Certain cardiac disorders such as recent myocardial infarction (MI), severe congestive heart failure, certain types of abnormal cardiac rhythm
- Uncontrolled high blood pressure despite medications
- Uncontrolled, clinically significant active infection.
- Known hypersensitivity to any of the components of CA4P, paclitaxel, carboplatin, bevacizumab, or radiologic contrast dyes.
Details of the above and additional inclusion and exclusion criteria can be discussed with an investigator.
Trial Contact Information
Trial Lead Organizations/Sponsors Oxigene, Incorporated Trial Sites
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| U.S.A. |
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| California |
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Campbell |
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| | | | | | | | | Southbay Oncology / Hematology Medical Group |
| | | Marta Roeder |
Ph: 408-376-2310 |
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Email:
marta@sbohp.com |
| | | Steven Scates, MD | Principal Investigator |
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Fountain Valley |
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| | | Pacific Coast Hematology/Oncology Medical Group, Incorporated |
| | | Catherine Etheredge |
Ph: 714-845-0238 |
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Email:
cetheredge@pchomg.net |
| | | Richard Jacoub, MD | Principal Investigator |
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Los Angeles |
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| | | Jonsson Comprehensive Cancer Center at UCLA |
| | | Nathalie Chorn |
Ph: 310-825-4493 |
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Email:
nchorn@mednet.ucla.edu |
| | | Edward Garon, M.D. | Principal Investigator |
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| Kentucky |
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Louisville |
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| | | | Kentuckiana Cancer Institute, PLLC |
| | | Roxanne Smalley |
Ph: 502-561-1178 Ext.285 |
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Email:
rsmalley@kci.us |
| | | Alfonse Cervera, MD | Principal Investigator |
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| Massachusetts |
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Burlington |
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| | | | Lahey Clinic Medical Center - Burlington |
| | | Julie Roache |
Ph: 781-744-3055 |
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Email:
julie.roache@lahey.org |
| | | Todd Shuster, MD | Principal Investigator |
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| New Jersey |
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Cherry Hill |
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| | | | Center for Cancer and Hematologic Disease - Cherry Hill |
| | | Nancey DiNubile |
Ph: 856-424-7983 Ext.1702 |
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Email:
n.dinubile@centerforcancer.com |
| | | Stephen Zrada, MD | Principal Investigator |
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| New Mexico |
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Farmington |
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| | | | San Juan Oncology Associates, PC |
| | | Rosemarie Mestas |
Ph: 505-599-6049 |
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Email:
rmestas@sjrmc.net |
| | | James Neidhart, M.D. | Principal Investigator |
| | | Jeffrey Neidhart, MD | Sub-Investigator |
| | | Daniel Costello, PA-C | Sub-Investigator |
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| Ohio |
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Canton |
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| | | | Gabrail Cancer Center - Canton Office |
| | | Carrie L Smith, RN |
Ph: 330-492-3345 Ext.208 |
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Email:
csmith@gabrailcancercenter.com |
| | | Nashat Yousif Gabrail | Principal Investigator |
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Middletown |
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| | | Signal Point Clinical research |
| | | Susan Smith |
Ph: 513-423-0504 |
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Email:
susan_smith@swohio.twcbc.com |
| | | Nandagopal Vrindavanam, MD | Principal Investigator |
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| Virginia |
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Salem |
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| | | | Blueridge Cancer Care |
| | | Crystal Harrington |
Ph: 540-774-8660 Ext.227 |
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Email:
crystal.harrington@usoncology.com |
| | | Paul D Richards, MD | Principal Investigator |
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| Washington |
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Tacoma |
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| | | | Northwest Medical Specialties, PLLC - Tacoma |
| | | Tina Schied |
Ph: 253-428-8756 |
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Email:
tschied@nwmsonline.com |
| | | Mark Nelson |
Ph: 253-428-8756 |
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Email:
mnelson@nwmsonline.com |
| | | Moacyr Oliveira, M.D. | Principal Investigator |
| | | Lorrin K. Yee | Sub-Investigator |
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| West Virginia |
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Morgantown |
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| | | | Mary Babb Randolph Cancer Center at West Virginia University Hospitals |
| | | Dawn Scopel |
Ph: 304-293-7375 |
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Email:
dscopel@hsc.wvu.edu |
| | | John Rogers, M.D. | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00653939
Information obtained from ClinicalTrials.gov on September 26, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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