Esophageal Cancer Clinical Trial
Official title:
A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Verified date | May 2016 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. Of the 40 patients on this trial, 60% of the patients showed a response of some kind and the regimen was well tolerated. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.
Status | Active, not recruiting |
Enrollment | 35 |
Est. completion date | June 2016 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed, unresectable esophageal or gastric carcinoma (carcinoma=adenocarcinoma or squamous cell carcinoma) - Measurable disease greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan or 2 cm or greater by other radiographic technique - Lesions must be measurable in at least one dimension - Bone lesions, ascites, and effusions are not measurable - 18 years of age or older - ECOG performance status 0 or 1 - Life expectancy of at least 12 weeks - Adequate bone marrow function - Adequate renal function - Adequate liver function Exclusion Criteria: - Prior chemotherapy (except as part of pre- or post-operative therapy, completed more than 1 year prior to start day of this protocol) - History of severe hypersensitivity to bevacizumab, docetaxel, cisplatin, irinotecan, or drugs formulated with polysorbate 80 - Current, recent (within 4 weeks) or planned participation in an experimental drug study - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study - Minor surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies within 7 days prior to Day 0 of study - Myocardial infarction or stroke in past 6 months - Blood pressure of > 150/100 mmHg - Unstable angina - New York Heart Association (NYHA) grade II or greater congestive heart failure - Clinically significant peripheral vascular disease - Persistent bleeding from primary tumor, while off anticoagulants, requiring repeated transfusions - Evidence of bleeding diathesis or coagulopathy - Uncontrolled serious medical or psychiatric illness - Uncontrolled diarrhea - Peripheral neuropathy > grade 1 - Clinically apparent central nervous system metastases or carcinomatous meningitis - Other active malignancy other than non-melanoma skin cancer or in situ cervical carcinoma. - Urine protein: creatinine ratio of 1.0 or greater at screening - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 - Serious non-healing wound, ulcer, or bone fracture - Pregnant or breast-feeding |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital, Genentech, Inc., Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the 10-month progression-free survival for the combination of TPC plus bevacizumab in this patient population and to compare this result to the 10-month progression-free survival with TPC alone in these patients | 2 years | No | |
Secondary | To determine the response rate (Response Evaluation Criteria in Solid Tumors [RECIST]), median duration of response, overall survival, and toxicity of the TPC plus bevacizumab regimen and to compare these results to TPC alone | 2 years | Yes |
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