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AzTrials

Esophageal CancerPhase 2NCT00017043

BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With Chemotherapy

A Phase 2 study testing ixabepilone in people with Esophageal Cancer and Gastric Cancer, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
ixabepilone
How many people
Not given
Where
1 siteUnited States
Study dates
Feb 2001to Jan 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
ixabepilone
Keywords
stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ixabepiloneDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2003 (estimated)
  2. Study startFeb 2001
  3. Primary completionJan 2003
  4. Study completionJan 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017043
Sponsor's protocol ID
CDR0000068644
Other IDs
BMS-MSKCC-01011, MSKCC-01011, NCI-G01-1949
Status last verified
Apr 2013
First submitted
6 Jun 2001
Last updated
5 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone in people with Esophageal Cancer and Gastric Cancer, run by Bristol-Myers Squibb at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013.

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