Doxorubicin, Cisplatin, 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus

Adenocarcinoma of Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165191
• Other study ID #: 98-048
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: April 27, 2009
• Start date: August 1998
• Est. completion date: January 2006

Study information

• Verified date: April 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to collect information on the anti-tumor activity of the combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma. We will also be collecting information about the side effects and safety of this combination.

Description:

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Esophagus
• Adenocarcinoma of GE Junction
• Adenocarcinoma of Stomach
• Esophageal Neoplasms

Intervention

Drug:
• Doxorubicin

• Cisplatin

• 5-fluorouracil

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Assess the safety of doxorubicin, cisplatin and 5-fluorouracil when given in combination to treat this patient population
Secondary	evaluate the survival of this patient population.