Know Cancer

forgot password

A Phase II Study of Caelyx in the Treatment of Advanced Gastric Cancer

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

A Phase II Study of Caelyx in the Treatment of Advanced Gastric Cancer

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth O'Byrne, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals, Leicester


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms