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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
N/A
Not Enrolling
Both
Stomach Neoplasms, Esophageal Neoplasms

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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


Primary Objective

- To determine the efficacy of modified docetaxel, cisplatin, and fluorouracil (mDCF)
with bevacizumab in patients with unresectable or metastatic gastric, gastroesophageal
junction (GEJ), or esophageal adenocarcinoma as measured by 6 month progression free
survival (PFS)

Secondary Objectives

- To establish the safety of mDCF with bevacizumab in patients with unresectable or
metastatic gastroesophageal adenocarcinoma.

- To observe other measures of efficacy of mDCF with bevacizumab, including response
rate, median PFS, overall and 1-year survival in patients with unresectable or
metastatic gastroesophageal adenocarcinoma.

- To explore coagulation activation in patients with unresectable or metastatic
gastroesophageal adenocarcinoma.

- To explore the association of early FDG-PET/CT imaging with treatment efficacy.

- To bank tumor biopsy material for future planned correlative studies for association
with chemotherapy efficacy and survival.


Inclusion Criteria:



- Patients must have histologically or cytologically confirmed metastatic or
unresectable gastric or esophageal adenocarcinoma, including GEJ adenocarcinoma which
will be classified according to Siewert's classification type I, II, or III.

- Histological documentation of local recurrence or metastasis is strongly encouraged,
unless the risk of such a procedure outweighs the potential benefit of confirming the
metastatic disease.

- If no histologic confirmation, then the metastases or recurrence will require
documentation by a 2nd radiographic procedure (i.e. positron emission tomography
[PET] scan or magnetic resonance imaging [MRI] in addition to the computed tomography
[CT] scan). If the imaging procedure does not confirm recurrent or metastatic
disease, biopsy confirmation will be required.

- Patients must have disease that can be evaluated radiographically. This may be
measurable disease or non-measurable disease. Measurable disease is defined as that
which can be measured in at least one dimension as > or = 20 mm with conventional
techniques, or > or = 10 mm by high resolution imaging. Disease that is identified
on radiology studies, but does not meet the criteria for measurable disease, is
considered non-measurable - see section 12.1.1 of protocol for further details.

- No prior chemotherapy for metastatic or unresectable disease. Patients may have
received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6
months have elapsed between the end of adjuvant therapy and registration. Patients
may not have received prior docetaxel or cisplatin, or bevacizumab or any other novel
biologic anti-angiogenic agent.

- Age 18 years or older.

- Karnofsky performance status > or = 70% (ECOG performance status 0-1).

- Peripheral neuropathy < or = grade 1

- Hematologic (minimal values):

- White blood cell count > or = 3000/mm3

- Absolute neutrophil count > or = 1500 cells/mm3

- Hemoglobin > or = 9.0 g/dl

- Platelet count > or = 100,000/mm3

- Hepatic (minimal values):

- Total bilirubin < or = to upper limit of normal (ULN)

- AST and ALT and alkaline phosphatase must be within the eligible range. In
determining eligibility, the more abnormal of the two values (AST or ALT) should
be used. AST and ALT and alkaline phosphatase should be no more than 1-1.5 times
the upper limit of normal.

- Kidney function (minimal values):

- Serum creatinine < or = 1.5 mg/dl

- Urinalysis < 2+ proteinuria; urine protein (mg/dl)/urine creatinine (mg/dl)
ratio (Up/c) < 1.0

- The patient has a PT (INR) < or = 1.5 and a PTT < or = 3 seconds above the upper
limits of normal if the patient is not on anticoagulation therapy. If a patient is on
full-dose anticoagulants, the following criteria should be met for enrollment:

1. The patient must have an in-range INR (usually between 2 and 3) on a stable dose
of warfarin or on stable dose of LMW heparin.

2. The patient must not have active bleeding or pathological conditions that carry
high risk of bleeding (e.g. tumor involving major vessels, known varices).

- Women of childbearing potential must have a negative pregnancy test. Men and women of
childbearing potential must be willing to consent to using effective contraception
while on treatment and for at least 3 months thereafter.

- Ability to understand informed consent and signing of written informed consent
document prior to initiation of protocol therapy.

Exclusion Criteria:

- Patients who have received previous chemotherapy for the treatment of metastatic or
unresectable gastric, GEJ, or esophageal adenocarcinoma are ineligible. Patients who
have received previous pre- or post-operative chemotherapy or chemoradiation are
ineligible if therapy was completed less than 6 months prior to study registration.
Patients must have recovered from adverse events from any previous therapy.

- Patients who have received previous bevacizumab, docetaxel, or cisplatin.

- Patients with a history of another neoplastic disease within the past three years,
excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or
nonmetastatic prostate cancer.

- Patients with brain or central nervous system metastases, including leptomeningeal
disease.

- Minor surgical procedure such as fine needle aspiration, core biopsy, laparoscopy, or
mediport placement within 7 days prior to initiating treatment.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to day 0

- Anticipation of need for major surgical procedure during the course of the study.

- Pregnant (positive pregnancy test) or breast feeding.

- Urine protein:creatinine (Up/c) ratio > or = 1.0 at screening

- History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess
within 6 months prior to the initiation of treatment.

- Serious, non-healing wound, ulcer, or bone fracture.

- Blood pressure > 150/100 mmHg

- Significant cardiac disease defined as:

- Unstable angina

- New York Heart Association (NYHA) grade II or greater

- Congestive heart failure

- History of myocardial infarction within 6 months

- Evidence of bleeding diathesis or coagulopathy.

- History of a stroke or cerebrovascular accident (CVA) within 6 months.

- Clinically significant peripheral vascular disease.

- Clinically significant hearing loss or ringing in the ears.

- Patients with a history of severe hypersensitivity reaction to Taxotere® or other
drugs formulated with polysorbate 80.

- Inability to comply with study and/or follow-up procedures.

- Patients with any other medical condition or reason, in the investigator's opinion,
that makes the patient unstable to participate in a clinical trial.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the efficacy of modified docetaxel, cisplatin, and fluorouracil with bevacizumab in patients with unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma as measured by 6 month progression free survival

Outcome Time Frame:

6 month to progression free survival

Safety Issue:

No

Principal Investigator

David Ilson, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-096

NCT ID:

NCT00390416

Start Date:

October 2006

Completion Date:

January 2012

Related Keywords:

  • Stomach Neoplasms
  • Esophageal Neoplasms
  • Metastatic
  • Gastroesophageal
  • Docetaxel
  • Cisplatin
  • Fluorouracil
  • Bevacizumab
  • Metastatic Gastroesophageal Adenocarcinoma
  • 06-096
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville Centre, New York  11570
Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering Cancer Center 1275 York AvenueNew York, New York  10021
Memoral Sloan Kettering Cancer Center@Phelps Memorial HospitalSleepy Hollow, New York