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

Esophageal Cancer Clinical Trial

Official title:

A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00394433
• Other study ID #: 06-100
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 31, 2006
• Last updated: May 9, 2016
• Start date: September 2006
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: June 2016
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Stomach Cancer
• Stomach Neoplasms

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Genentech, Inc., Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years	No
Secondary	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		2 years	Yes