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Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer
This study is ongoing, but not recruiting participants.
First Received: January 28, 2000   Last Updated: July 23, 2008   History of Changes
Sponsored by: University Hospitals, Leicester
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004236
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced stomach cancer.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Caelyx in the Treatment of Advanced Gastric Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1998
Detailed Description:

OBJECTIVES: I. Determine overall survival, time to disease progression, objective reponse rate, safety profile, and quality of life in patients with inoperable gastric adenocarcinoma when treated with doxorubicin HCl liposome.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour every 4 weeks. Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease may continue therapy past the 6 courses until documented disease progression. Quality of life is assessed prior to every treatment course. All patients are followed at 1 month. Patients with stable or responding disease are then followed every 3 months until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced gastric adenocarcinoma, including adenocarcinoma of the esophagogastric junction Evaluable disease No CNS involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin normal AST or ALT less than 3 times upper limit of normal (ULN) (5 times ULN if documented liver metastases) Renal: Creatinine less than 1.5 times ULN Cardiovascular: LVEF normal No history of New York Heart Association class II-IV heart disease with congestive heart failure No unstable cardiovascular disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior primary cancer within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No hypersensitivity to anthracycline therapy No history of severe hypersensitivity reactions to products containing Chremophor EL (e.g., cyclosporine or teniposide for injection concentrate) No other significant medical disorder (e.g., active uncontrolled infection) that would preclude study treatment

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to less than 1/3 of hematopoietic sites and recovered Surgery: Not specified Other: At least 30 days since other prior investigational agents

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004236

Locations
United Kingdom, England
University Hospitals of Leicester
Leicester, England, United Kingdom, LE1 5WW
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
Study Chair: Kenneth O'Byrne, MD University Hospitals, Leicester
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067480, LRI-IND.02-3/98, EU-99034
Study First Received: January 28, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004236     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Doxorubicin
Recurrence
Anti-Bacterial Agents
Digestive System Diseases
Stomach Diseases
Esophageal Disorder
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer
Esophageal Diseases
Adenocarcinoma

Additional relevant MeSH terms:
Digestive System Neoplasms
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Neoplasms
Digestive System Diseases
Neoplasms by Site
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009