Overview

This trial is active, not recruiting.

Conditions esophageal cancer, gastric cancer, stomach cancer
Treatments bevacizumab, cisplatin, irinotecan, docetaxel
Phase phase 2
Target VEGF
Sponsor Dana-Farber Cancer Institute
Collaborator Massachusetts General Hospital
Start date July 2009
End date December 2014
Trial size 86 participants
Trial identifier NCT00911820, 09-039

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
PCA: Cisplatin, Irinotecan and Bevacizumab
bevacizumab
Given intravenously on day one of every 3 week cycle
cisplatin
Given intravenously on days 1 and 8 of each three week cycle
irinotecan
Given intravenously on days 1 and 8 of every three week cycle
(Active Comparator)
TPCA: Docetaxel, Cisplatin, Irinotecan, and Bevacizumab
bevacizumab
Given intravenously on day one of every 3 week cycle
cisplatin
Given intravenously on days 1 and 8 of each three week cycle
irinotecan
Given intravenously on days 1 and 8 of every three week cycle
docetaxel
Given intravenously on days 1 and 8 of every three week cycle.

Primary Outcomes

Measure
To evaluate progression-free survival for each regimen (PCA versus TPCA) at 7 months.
time frame: 3 years

Secondary Outcomes

Measure
Evaluation of overall survival for each of the regimens.
time frame: 3 years
To determine response rate (per RECIST criteria) for patients with measurable disease.
time frame: 3 years
Evaluation of the type and severity of toxicities associated with each of the regimens.
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title A Randomized, Multicenter, Phase II Trial of Cisplatin, Irinotecan and Bevacizumab (PCA) vs. Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Principal investigator Peter C. Enzinger, MD
Description - Because no one knows which of the study options is best, participants will be randomized into one of the two study groups: Arm A or Arm B. - For both Arm A and Arm B, the chemotherapy will be given in an outpatient setting, once a week for two weeks in a row, with a rest period for the third week. This three week period of time is called a cycle. - During week one Arm A (PCA) participants will receive bevacizumab, cisplatin, and irinotecan. Arm B (TPCA) participants will receive bevacizumab, docetaxel, cisplatin and irinotecan. - During week two, participants will return to the clinic to receive chemotherapy (both arms will receive the chemotherapy agents and not bevacizumab). Blood tests and vital signs will also be collected. - After 2 cycles of chemotherapy, participants will have CT scans done to see how their tumor is responding to the chemotherapy.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.