Clinical trial NCT00017043: BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With Chemotherapy
Official title: A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: stage IV gastric cancer
recurrent gastric cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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 BMS-247550 in treating patients who have metastatic stomach cancer previously treated with chemotherapy.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Manish A. Shah, MD
role: STUDY_CHAIR
References: