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

Phase 2
18 Years
Open (Enrolling)
Gastroesophageal Junction Adenocarcinoma, Gastric Cancer

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Trial Information

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

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed metastatic or
unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. GEJ
adenocarcinoma may be classified according to Siewert's classification type I, II, or

- 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 (eg. PET/CT scan or MRI in addition to
the 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 > 20 mm with conventional
techniques, 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.

- Patients may have received 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

- Age 18 years or older.

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

- Peripheral neuropathy < than or = to grade 1.

- Hematologic (minimal values):

- White blood cell count > than or = to 3000/mm3

- Absolute neutrophil count > than or = to 1500 cells/ mm3

- Hemoglobin > than or = to 9.0 g/dl

- Platelet count > than or = to 100,000 / mm3

- Hepatic (minimal values):

- Total bilirubin < or = to 1.5

* * 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. Patients with alkaline phosphatase elevation secondary to the bony metastases
rather than liver dysfunction may proceed with treatment on protocol after discussion
with the principal investigator.

- Kidney function (minimal values):

* Serum creatinine < than or = to 1.5 mg/dl - if serum creatinine is 1.2-1.5 mg/dl,
the creatinine clearance (either measured or calculated) must be 50 ml/min or greater

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

- 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

- 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 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.

- Patients must have HER2-positive (FISH+ or IHC 3+) metastatic or unresectable gastric
or gastroesophageal junction (GEJ) adenocarcinoma to be eligible for trastuzumab. For
the purposes of this protocol, FISH+ is defined as HER2:CEP17 ratio ≥ 2.0. Biopsy
samples with cohesive IHC3+ or FISH+ clones are considered HER2 positive irrespective
of size, i.e.<10%. FISH+ defined as >2 HER2:CEP17.

- Patients who are receiving trastuzumab must have a left ventricular ejection fraction
of ≥ 50%.

Exclusion Criteria:

- Patients who have received previous chemotherapy for the treatment of metastatic or
unresectable gastric or GEJ 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 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

- Pregnant (positive pregnancy test) or breast feeding.

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

- Significant cardiac disease as 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 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 that investigator's opinion,
makes the patient unstable to participate in a clinical trial.

- For patients who are Her2 positive and will be treated on the trastuzumab + mDCF
cohort, prior trastuzumab treatment is not allowed.

- For patients who are Her2 positive and will be treated on the trastuzumab+mDCF
cohort, left ventricular function <50%

Type of Study:


Study Design:

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

Outcome Measure:

The primary endpoint for both arms is progression free survival (PFS), as measured from the start of the treatment to the date of either documentation of disease progression or death.

Outcome Time Frame:

progression or death

Safety Issue:


Principal Investigator

Yelena Janjigian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2006

Completion Date:

October 2013

Related Keywords:

  • Gastroesophageal Junction Adenocarcinoma
  • Gastric Cancer
  • gastroesophageal junction
  • gastric cancer
  • adenocarcinoma
  • unresectable gastric cancer
  • metastatic gastric
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Weill Medical College of Cornell University New York, New York  10021
Long Island Jewish Medical Center New Hyde Park, New York  11040
University Hospital of Cleveland Cleveland, Ohio  44106
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York, New York  10021
Memorial Cancer Institute Pembroke Pines, Florida  33028
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital Sleepy Hollow, New York  
Piedmont Hospital Research Institute Atlanta, Georgia  30309
City of Hope Cancer Center Duarte, California  91010
Nebraska Cancer Specialists, Methodist Estabrook Cancer Center Omaha, Nebraska  68114
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York