Esophageal Cancer Clinical Trial
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Summary
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. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.
Full Description
OBJECTIVES:
Primary
To determine the 10-month progression-free survival rate for the combination of TPC and Bevacizumab in patients with metastatic esophageal or gastric cancer
Secondary
To determine the response rate (RECIST) and median duration of response
To determine overall survival
To determine toxicity
Exploratory
To explore if 7/7 and 7/6 UGT1A1 polymorphisms correlate with grade III/IV irinotecan-related diarrhea and neutropenia when irinotecan is given at relatively low dose to patients with esophageal and gastric cancer
To correlate expression of tumoral and serum VEGF with response and survival
To correlate TGF alpha levels and tumor microvessel density with clinical activity
To examine circulating endothelial cells (CECs) as surrogate markers of antitumor activity of bevacizumab
DESIGN This trial will use a single stage design to differentiate a >/= 50% rate of 10-month progression-free survival from a
Eligibility Criteria
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
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There are 2 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
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