Status:
COMPLETED
Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
SCRI Development Innovations, LLC
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There is no clear standard of care for metastatic stomach or esophageal cancer in the United States. The purpose of this research study is to determine the differences between two regimens of chemothe...
Detailed Description
OBJECTIVES: Primary \* To evaluate progression-free survival at 7 months in metastatic esophageal and gastric patients treated with either PCA or TPCA Secondary * To determine overall survival * T...
Eligibility Criteria
Inclusion
- Histologically confirmed, unresectable esophageal, GE junction or gastric adenocarcinoma (including adenosquamous, or undifferentiated carcinoma). Measurable disease is not required.
- 18 years of age or older
- ECOG Performance Status=2
- Life expectancy of 12 weeks or greater
- Adequate bone marrow, renal and liver function as outlined in the protocol.
- Men and women of childbearing potential must use adequate contraception
Exclusion
- Prior chemotherapy (except as part of pre- or post-operative therapy, completed at least 1 prior to start of this protocol).
- Squamous cell carcinoma histology of esophageal, GE junction or gastric tumor
- Known history of allergy or hypersensitivity to Chinese hamster ovary products, polysorbate 80, or any of the study drugs
- Treatment or planned participation in an experimental drug study within 4 weeks of C1 D1. Concurrent use of herbal medications or other alternative therapies
- Major surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies, within 7 days of cycle 1 day 1
- Palliative radiation to 25% or less of bone marrow, must be completed \> 2 weeks prior to day 1, palliative radiation to \> 25% of bone marrow, must be completed \> 4 weeks prior to day 1
- Myocardial infarction, unstable angina, CVA or TIA or other thrombotic event in the past six months
- Inadequately controlled hypertension (defined as systolic blood pressure of \>150mmHg and/or diastolic blood pressure of \> 100mmHg). Initiation of antihypertensive medication is recommended, however adequate control of blood pressure must be documented prior to C1 D1
- No history of prior hypertensive crisis or hypertensive encephalopathy
- NYHA Grade II or greater congestive heart failure
- Clinically significant peripheral vascular disease
- Active bleeding from primary tumor
- Evidence of bleeding diatheses or coagulopathy (other than deep venous thrombosis, portal vein thrombosis, pulmonary embolism, or atrial fibrillation). Patients on therapeutic anticoagulation may be enrolled provided they have been clinically stable on anticoagulation for a least 2 weeks prior to C1 D1.
- Uncontrolled serious medical or psychiatric illness
- Uncontrolled diarrhea
- Peripheral neuropathy
- No known brain or other CNS metastasis by history or clinical examination
- Other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected or previously treated cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years
- Urine protein:creatinine ratio 1.0 or greater at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess with 6 months of C1 D1
- Serious, non-healing wound, ulcer or bone fracture
- Pregnant or breast feeding
- Inability to comply with study and/or follow-up procedures
- History of HIV seropositivity, hepatitis C virus, acute or chronic hepatitis B, or other serious chronic infection
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00911820
Start Date
July 1 2009
End Date
August 1 2013
Last Update
November 8 2022
Active Locations (4)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
4
Texas Oncology Research
Dallas, Texas, United States, 75251