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A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of Stomach, Adenocarcinoma of GE Junction, Adenocarcinoma of Esophagus

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Trial Information

A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus


- Patients will receive cisplatin and doxorubicin intravenously once every 3 weeks. In
addition to cisplatin and doxorubicin, patients will receive 5-fluorouracil
intravenously as a continuous infusion for the duration of the study. In order to do
this, patients will receive an infusion pump that can be carried with them. Treatment
cycles will be repeated every 21 days for a maximum of 8 cycles.

- Prior to enrollment in this study and while the patient is receiving the therapy,
routine blood tests and x-ryas (including chest x-rays and CT scans) will be performed
to check the body's response to the treatment. Blood tests will be checked once a week
and chest x-rays and CT scans will be checked every 6 weeks.

- Patients with progressive disease or intolerable side effects will be removed from the
study. Patients with stable disease or tumor response will continue therapy for a
maximum of 8 cycles.


Inclusion Criteria:



- Measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE
junction or esophagus

- No more than one prior chemotherapy regimen

- ECOG performance status of < or equal to 2

- Life expectancy > 12 weeks

- ANC > 1,500/mm3

- Hemoglobin > 9.0 gm/dl

- Platelets > 100,000/mm3

- SGOT < 3 x ULN

- Total bilirubin < 2.0 mg/dl

- Creatinine < 1.5 mg/dl

Exclusion Criteria:

- Prior cisplatin or doxorubicin as neoadjuvant or adjuvant therapy with in 1 year of
study entry

- Clinically apparent central nervous system metastases or carcinomatous meningitis

- Myocardial infarction in the past 6 months

- Major surgery in the past 2 weeks

- Uncontrolled serious medical or psychiatric illness

- Pregnant or lactating women

- Concurrent malignancy of any site, except limited basal cell carcinoma or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix

- History or clinical evidence of congestive heart failure

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 activity of doxorubicin, cisplatin and continuous infusion of 5-fluorouracil in patients with measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction, or esophagus.

Principal Investigator

Matthew Kulke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

98-048

NCT ID:

NCT00165191

Start Date:

August 1998

Completion Date:

January 2006

Related Keywords:

  • Adenocarcinoma of Stomach
  • Adenocarcinoma of GE Junction
  • Adenocarcinoma of Esophagus
  • doxorubicin
  • cisplatin
  • 5-fluorouracil
  • stomach cancer
  • esophagus cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617