Esophageal Cancer Clinical Trial
Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
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 chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA (Docetaxel, Cisplatin, Irinotecan and Bevacizumab). Docetaxel, Cisplatin, and Irinotecan are traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body). Bevacizumab is believed to stop the formation of new blood vessels that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been studied in patients with esophageal and gastric cancer, and we are trying to determine if one regimen will keep your cancer from growing and improve how long you can live.
* To evaluate progression-free survival at 7 months in metastatic esophageal and gastric patients treated with either PCA or TPCA
To determine overall survival
To determine the response rate (RECIST) in measurable disease patients
To evaluate type and severity of toxicities associated with each regimen
To correlate expression of tumoral and serum VEGF with response and survival
To correlate TGF alpha levels and tumor microvessel density with clinical activity of the combination of PCA or TPCA
To examine circulating endothelial cells (CECs) as surrogate markers of antitumor activity of bevacizumab
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
This trial was designed to compare 7-month progression-free survival between arms. The hypothesis was that TPCA would have superior outcome over PCA (70% vs 50%). With 40 eligible patients per arm followed for 1 year there was 80% power to detect a hazard ratio of 0.48 using the log-rank test at a one-sided type I error rate of 5%. Stratification factors were ECOG performance status 0/1 vs 2 and site of primary tumor (gastric vs GE junction/esophageal).
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
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
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
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There are 4 Locations for this study
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02214, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75251, United States
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