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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Doxorubicin

Cisplatin

5-fluorouracil

About this trial

This is an interventional treatment trial for Adenocarcinoma of Stomach focused on measuring doxorubicin, cisplatin, 5-fluorouracil, stomach cancer, esophagus cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana-Farber Cancer Institute
Massachusetts General Hospital

Outcomes

Primary Outcome Measures

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 Outcome Measures

Assess the safety of doxorubicin, cisplatin and 5-fluorouracil when given in combination to treat this patient population

evaluate the survival of this patient population.

Full Information

NCT ID

NCT00165191

First Posted

September 9, 2005

Last Updated

April 27, 2009

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00165191

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

August 1998 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of Stomach, Adenocarcinoma of GE Junction, Adenocarcinoma of Esophagus

Keywords

doxorubicin, cisplatin, 5-fluorouracil, stomach cancer, esophagus cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Type

Drug

Intervention Name(s)

5-fluorouracil

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Assess the safety of doxorubicin, cisplatin and 5-fluorouracil when given in combination to treat this patient population

Title

evaluate the survival of this patient population.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Kulke, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Adenocarcinoma of Stomach, Adenocarcinoma of GE Junction, Adenocarcinoma of Esophagus

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial