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.
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
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.
- Conditions
- Esophageal Cancer, Gastric Cancer
- 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.
- First posted9 Sep 2003 (estimated)
- Study startFeb 2001
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Manish A. Shah, MD, Study chair, Memorial Sloan Kettering Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane
- ClinicalTrials.gov ID
- NCT00017043
- Acronym / sponsor ID
- CDR0000068644
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2001
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 9 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ixabepilone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish A. Shah, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
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.