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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Genentech
Information provided by (Responsible Party):
Peter C. Enzinger, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00394433
First received: October 31, 2006
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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. Of the 40 patients on this trial, 60% of the patients showed a response of some kind and the regimen was well tolerated. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of 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 determine the 10-month progression-free survival for the combination of TPC plus bevacizumab in this patient population and to compare this result to the 10-month progression-free survival with TPC alone in these patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the response rate (Response Evaluation Criteria in Solid Tumors [RECIST]), median duration of response, overall survival, and toxicity of the TPC plus bevacizumab regimen and to compare these results to TPC alone [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: September 2006
Estimated Study Completion Date: December 2013
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    Given intravenously once a week for 2 weeks followed by a one week rest period (3 weeks equals one cycle). Participants will receive at least two cycles of treatment.
    Drug: Docetaxel
    Given intravenously once a week for 2 weeks followed by a one week rest period (3 weeks equals one cycle). Participants will receive at least two cycles of treatment.
    Drug: Cisplatin
    Given intravenously once a week for 2 weeks followed by a one week rest period (3 weeks equals one cycle). Participants will receive at least two cycles of treatment.
    Drug: Irinotecan
    Given intravenously once a week for 2 weeks followed by a one week rest period (3 weeks equals one cycle). Participants will receive at least two cycles of treatment.
Detailed Description:

Participants' chemotherapy will be given once a week for two weeks in a row, with a rest period on the third week. This three week period of time is called a cycle.

Week 1 (Cycle 1): The nurse in the infusion clinic will start an intravenous line to give premedications, fluid and the chemotherapy. Bevacizumab is only given on day 1 of each cycle and is infused over 90 minutes. Docetaxel, cisplatin and irinotecan will each be given over 30 minutes.

Week 2 (Cycle 1): The following tests and procedures will be performed prior to the administration of chemotherapy; blood tests, height, weight, vital signs, review of medications and any side effects. Once the tests and procedures are complete, docetaxel, cisplatin and irinotecan will each be administered over 30 minutes.

If the participants' cancer is still present in the esophagus or stomach, the doctor will offer the option of reevaluating the tumor with endoscopy. The doctor will look for signs that the tumor is dying and any evidence of bleeding. A biopsy will be done during this procedure.

Week 1 (Cycle 2 and all future cycles): On day one of each cycle the participant will undergo the following: Medical history and physical exam including vital signs; blood tests; bevacizumab, docetaxel, cisplatin and irinotecan infusions.

Week 2 (Cycle 2 and all future cycles): The following tests and procedures will be performed: blood tests; vital signs; side effect evaluation; docetaxel, cisplatin and irinotecan infusions.

After every 2 cycles of chemotherapy, a urinalysis to test for protein in the urine, and CT scans to measure the tumor will be performed.

Participants will be in this research study for at least 2 cycles. After the CT scan, if the study doctor thinks this regimen of chemotherapy is helping and the tumors are stable or shrinking, the participant can continue on the study.

  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 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
  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: NCT00394433

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Genentech
Investigators
Principal Investigator: Peter Enzinger, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Peter C. Enzinger, MD, Overall PI, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00394433     History of Changes
Other Study ID Numbers: 06-100
Study First Received: October 31, 2006
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
TPCA
Taxotere
Platinum
Avastin
Camptosar
gastric cancer

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

ClinicalTrials.gov processed this record on July 20, 2014