Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
SCRI Development Innovations, LLC
Texas Oncology Cancer Center
Genentech
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00911820
First received: May 29, 2009
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Stomach Cancer
Drug: Bevacizumab
Drug: Cisplatin
Drug: Irinotecan
Device: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate progression-free survival for each regimen (PCA versus TPCA) at 7 months. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of overall survival for each of the regimens. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine response rate (per RECIST criteria) for patients with measurable disease. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Evaluation of the type and severity of toxicities associated with each of the regimens. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 86
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
PCA: Cisplatin, Irinotecan and Bevacizumab
Drug: Bevacizumab
Given intravenously on day one of every 3 week cycle
Drug: Cisplatin
Given intravenously on days 1 and 8 of each three week cycle
Drug: Irinotecan
Given intravenously on days 1 and 8 of every three week cycle
Active Comparator: Arm B
TPCA: Docetaxel, Cisplatin, Irinotecan, and Bevacizumab
Drug: Bevacizumab
Given intravenously on day one of every 3 week cycle
Drug: Cisplatin
Given intravenously on days 1 and 8 of each three week cycle
Drug: Irinotecan
Given intravenously on days 1 and 8 of every three week cycle
Device: Docetaxel
Given intravenously on days 1 and 8 of every three week cycle.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911820

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology Research
Dallas, Texas, United States, 75251
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
SCRI Development Innovations, LLC
Texas Oncology Cancer Center
Genentech
Investigators
Principal Investigator: Peter C. Enzinger, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00911820     History of Changes
Other Study ID Numbers: 09-039
Study First Received: May 29, 2009
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Bevacizumab
Docetaxel
Irinotecan
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014