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A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

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Trial Information

A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane


OBJECTIVES:

- Determine the clinical activity of BMS-247550, in terms of response rate, in patients
with previously treated metastatic gastric adenocarcinoma.

- Determine the safety of this drug in these patients.

- Assess the response duration, 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
2-18 courses in the absence of disease progression or unacceptable toxicity. Patients with a
complete response (CR) receive 4 additional courses after confirmation of CR.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-58 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma originating in the stomach or
gastroesophageal junction

- Failed prior taxane-based chemotherapy regimen* in the metastatic setting OR

- Relapsed within 6 months of completing taxane-based chemotherapy* in the
adjuvant setting

- Bidimensionally measurable metastatic disease

- No prior radiotherapy to only measurable target lesion

- No squamous cell or sarcomatous disease

- No known brain metastases NOTE: *Regimen must have included a fluopyrimidine and/or a
platinum drug

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/mm^3

- Platelet count greater than 125,000/mm^3

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 other malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No serious concurrent infection

- No nonmalignant uncontrolled medical illness that would preclude study

- No psychiatric disorder or other condition that would preclude study compliance

- No neuropathy (neuromotor or neurosensory) of grade 2 or greater

- No known severe hypersensitivity to agents containing Cremophor EL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after the
study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy for metastatic disease

- Prior neoadjuvant and adjuvant chemotherapy allowed

- No more than 1 prior chemotherapy regimen for metastatic disease

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except hormone replacement therapy

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No prior radiotherapy to major bone marrow-containing areas (e.g., pelvis or lumbar
spine)

- 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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Manish A. Shah, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068644

NCT ID:

NCT00017043

Start Date:

February 2001

Completion Date:

January 2003

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021