A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
18 Years
N/A
Both
Esophageal Cancer, Stomach Cancer
Trial Information
A Phase II Trial of Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Peter Enzinger, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
06-100
NCT ID:
NCT00394433
Start Date:
September 2006
Completion Date:
December 2013
Related Keywords:
- Esophageal Cancer
- Stomach Cancer
- TPCA
- Taxotere
- Platinum
- Avastin
- Camptosar
- gastric cancer
- Esophageal Diseases
- Esophageal Neoplasms
- Stomach Neoplasms
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
