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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

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer, Gastric Cancer, Stomach Cancer

Thank you

Trial Information

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

- 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.

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

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate progression-free survival for each regimen (PCA versus TPCA) at 7 months.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Peter C. Enzinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

March 2013

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • Stomach Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Sarah Cannon Research Institute Nashville, Tennessee  37203
Texas Oncology Research Dallas, Texas  75251