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A Phase II Study of Docetaxel, Cisplatin and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma

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

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Trial Information

A Phase II Study of Docetaxel, Cisplatin and Fluorouracil (Modified DCF) With Bevacizumab in Patients With Unresectable or Metastatic Gastroesophageal Adenocarcinoma



- Determine the efficacy of combination chemotherapy comprising modified docetaxel,
cisplatin, fluorouracil, and leucovorin calcium with bevacizumab, as measured by
6-month progression-free survival (PFS), in patients with locally recurrent,
unresectable, or metastatic gastric, gastroesophageal junction, or esophageal


- Determine the safety of this regimen in these patients.

- Determine other measures of efficacy of this regimen, including response rate, median
PFS, and overall and 1-year survival, in these patients.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive bevacizumab IV over 30 minutes, docetaxel IV over 1 hour, and leucovorin
calcium IV over 30 minutes on days 1, 15, and 29; fluorouracil IV continuously on days 1-3,
15-17, and 29-31; and cisplatin IV over 30 minutes on days 3, 17, and 31. Courses repeat
every 6 weeks for up to 6 months in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed gastric or esophageal adenocarcinoma

- Gastroesophageal junction adenocarcinoma classified according to Siewert's class
type I-III allowed

- Locally recurrent, metastatic, or unresectable disease

- If recurrent or metastatic disease is not histologically confirmed, then
documentation by a second radiographic procedure (i.e., positron emission
tomography scan or MRI in addition to CT scan) is required

- If the imaging procedure does not confirm recurrent or metastatic disease,
biopsy confirmation is required

- Measurable or nonmeasurable disease that can be radiographically evaluated

- Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm
by conventional techniques OR ≥ 10 mm by high-resolution imaging

- Nonmeasurable disease is defined as disease that can be identified on radiology
studies, but does not meet the criteria for measurable disease

- No brain or CNS metastases, including leptomeningeal disease


- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

- WBC ≥ 3,000/mm³

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- Bilirubin normal

- Creatinine ≤ 1.5 mg/dL

- Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:

- AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)

- AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN

- AP ≤ 5 times ULN AND AST and ALT normal

- Urinalysis < 2+ proteinuria

- Urine protein/urine creatinine ratio < 1.0

- PT (INR) ≤ 1.5 and PTT ≤ 3 seconds above ULN (if patient not on anticoagulation)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment

- No peripheral neuropathy > grade 1

- No other neoplastic disease within the past 3 years, except basal cell carcinoma of
the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer

- No significant traumatic injury within the past 28 days

- No abdominal fistula, gastrointestinal bleeding, or intraabdominal abscess within the
past 6 months

- No serious, nonhealing wound, ulcer, or bone fracture

- Blood pressure ≤ 150/100 mm Hg

- No significant cardiac disease, including any of the following:

- Unstable angina

- New York Heart Association class II-IV heart disease

- Congestive heart failure

- Myocardial infarction within the past 6 months

- No stroke or cerebrovascular accident within the past 6 months

- No clinically significant peripheral vascular disease

- No clinically significant hearing loss or ringing in the ears

- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80

- No other medical condition or reason that, in the opinion of the investigator, would
preclude study participation


- Recovered from prior therapy

- No prior chemotherapy for metastatic or unresectable disease

- No prior docetaxel, cisplatin, bevacizumab, or any other novel biologic
antiangiogenic agent

- More than 6 months since prior fluorouracil

- More than 6 months since prior adjuvant therapy (including chemotherapy and/or

- More than 7 days since prior minor surgery, including fine-needle aspiration, core
biopsy, laparoscopy, or mediport placement

- More than 28 days since prior major surgery or open biopsy

- No concurrent major surgery

- No other concurrent chemotherapy or anticancer therapy

- No concurrent immunotherapy or radiotherapy

- Concurrent full-dose anticoagulants allowed if the following criteria are met:

- In-range INR (usually 2-3) on a stable dose of warfarin or low molecular weight

- No active bleeding or pathological condition that carries a high risk of
bleeding (e.g., tumor involving major vessels or known varices)

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) as measured by RECIST criteria at 6 months

Safety Issue:


Principal Investigator

Minaxi Jhawer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center



Study ID:




Start Date:

October 2006

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • recurrent gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • recurrent esophageal cancer
  • stage IV esophageal cancer
  • stage III gastric cancer
  • stage III esophageal cancer
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021