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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165191
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 28, 2009
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Stomach Adenocarcinoma of GE Junction Adenocarcinoma of Esophagus Drug: Doxorubicin Drug: Cisplatin Drug: 5-fluorouracil Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
Study Start Date : August 1998
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006





Primary Outcome Measures :
  1. 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 :
  1. Assess the safety of doxorubicin, cisplatin and 5-fluorouracil when given in combination to treat this patient population
  2. evaluate the survival of this patient population.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165191


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
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Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
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ClinicalTrials.gov Identifier: NCT00165191    
Other Study ID Numbers: 98-048
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009
Keywords provided by Dana-Farber Cancer Institute:
doxorubicin
cisplatin
5-fluorouracil
stomach cancer
esophagus cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Fluorouracil
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs