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A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Gastric Adenocarcinoma Previously Treated With A Fluoropyrimidine And/Or Platinum

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Gastric Adenocarcinoma Previously Treated With A Fluoropyrimidine And/Or Platinum

OBJECTIVES: I. Determine the clinical activity of BMS-247550 in terms of response rate in
patients with recurrent metastatic gastric cancer previously treated with a fluoropyrimidine
or platinum regimen. II. Determine the safety of this drug in this patient population. III.
Determine the duration of response, time to progression, and survival of patients treated
with this drug.

OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 1 hour on day 1.
Treatment repeats every 21 days for up to 18 courses in the absence of disease progression
or unacceptable toxicity. Patients achieving a complete response (CR) receive up to 4
additional courses after CR. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-58 patients will be accrued for this study within 12

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent metastatic adenocarcinoma of
the stomach or gastroesophageal junction No squamous cell or sarcomatous elements in tumor
Previously treated with 1 prior fluoropyrimidine and/or platinum based chemotherapy
regimen for metastatic disease OR Recurrent disease within 6 months of completing adjuvant
fluoropyrimidine-containing therapy Bidimensionally measurable disease No known brain

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count
greater than 125,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal: Creatinine no greater than 2 times ULN Cardiovascular: No unstable angina,
myocardial infarction, or congestive heart failure within the past 6 months Other: No
grade 2 or greater neuropathy (motor or sensory) No other malignancy within the past 2
years except nonmelanoma skin cancer or carcinoma in situ of the cervix No serious
concurrent infection No other medical illness that would preclude study No psychiatric
disorder or other condition that would preclude study No known hypersensitivity to
Cremophor EL Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See
Disease Characteristics At least 3 weeks since prior chemotherapy Prior adjuvant or
neoadjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic
disease No prior taxane therapy No other concurrent chemotherapy Endocrine therapy: No
concurrent hormonal therapy except hormone replacement therapy Radiotherapy: At least 3
weeks since prior radiotherapy and recovered No prior radiotherapy to major bone
marrow-containing areas (pelvis, lumbar spine) or to only site of measurable disease No
concurrent therapeutic radiotherapy Surgery: At least 1 week since prior minor surgery and
recovered At least 3 weeks since prior major surgery and recovered Other: No other
concurrent experimental anticancer medications

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Manish A. Shah, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

January 2002

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021