Carcinoma, Non-small-cell LungPhase 2NCT00035516
A Phase II Study of Epothilone Analog BMS-247550 in Patients With Non-Small Cell Lung Cancer Who Have Failed First Line Platinum Based Chemotherapy
A Phase 2 study testing Epothilone in people with Carcinoma, Non-small-cell Lung, run by R-Pharm at 16 sites in United States.
Trial summary
The purpose of this clinical research study is to learn if BMS-247550 can shrink or slow the growth of the cancer in patients with non-small cell lung cancer who have failed first-line platinum based chemotherapy. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small-cell Lung
- What is being tested?
- Epothilone
- How many people
- Not given
- Where
- 16 sitesUnited States
- Study dates
- Feb 2001to Apr 2004
- 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
Who may be able to join
- Histologically or cytologically confirmed non-small cell lung cancer
- Bidimensionally measurable disease
- Progressed following therapy with one prior cisplatin or carboplatin based chemotherapy regimen for Stage III or IV or metastatic recurrent disease
- Adequate hematologic function as defined by: absolute neutrophils =/> 2,000/mm3, and platelets > 125,000/mm3
- Adequate hepatic function as defined by: serum bilirubin=/<1.5 times the upper institutional limits of normal, ALT =/< 2.5 times the upper institutional limits of normal (=/<5 times the upper institutional limits of normal if hepatic metastases are present
- Adequate renal function as defined: by serum creatine =/< 1.5 times the upper limits of normal
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- Adequate recovery from recent surgery, chemotherapy and radiation therapy. At least one week must have elapsed from the time of a minor surgery, at least 3 weeks for major surgery, chemotherapy and radiation therapy
- Life expectancy of at least 12 weeks
- ECOG performance status of 0-1
- At least 18 years old
- Willing and able to give written informed consent
- Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center
- Women of Child Bearing Potential (WOCP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within 72 hours prior to start of study medication.
- WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea=/>12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or, injectable intrauterine device or barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
Who cannot join
- More than one prior chemotherapy regimen for Stage IIIB or IV or for metastatic recurrent disease. Prior adjuvant or neoadjuvant chemotherapy is allowed.
- Patients who are candidates for curative resection.
- CTC Grade 2 or greater neuropathy (motor or sensory)
- Known brain metastases
- Prior radiation must have not included major bone marrow containing areas (pelvis, lumbar, spine) and must not have contained a target lesion as the only measurable lesion. A recovery period of at least 3 weeks after completion of radiotherapy is required prior to enrollment.
- Myocardial infarction, unstable angina, or any history of congestive heart failure within six months of study therapy
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- Pregnant or breast-feeding women, or sexually active women of childbearing potential not using an adequate method of birth control.
- Sexually active fertile men, whose partners are women of childbearing potential, unless using an adequate method of birth control
- Serious intercurrent infections, or nonmalignant medical illnesses that are controlled or whose control may be jeopardized by the complications of this therapy
- Psychiatric disorders or other conditions rendering the patient incapable of complying with the requirements of the the protocol
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Lahey Clinic
Burlington, Massachusetts, 01805
Unviversity of North Carolina
Chapel Hill, North Carolina, 27599
Rush Presbyterian St Lukes ME
Chicago, Illinois, 60612-3828
University of Missouri/Ellis Fischel Cancer Center
Columbia, Missouri, 65203
Dartmouth-Hitchcock /Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Consultants in Blood Disorders
Louisville, Kentucky, 40207
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Vanderbilt University Med School Div of Medical Oncology
Nashville, Tennessee, 37232-5536
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
Un of California Davis Cancer Center
Sacramento, California, 958177
H Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
The purpose of this clinical research study is to learn if BMS-247550 can shrink or slow the growth of the cancer in patients with non-small cell lung cancer who have failed first-line platinum based chemotherapy. The safety of this treatment will also be studied.
- Conditions
- Carcinoma, Non-small-cell Lung
- Being tested
- Epothilone
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpothiloneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startFeb 2001
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-small-cell LungStudies of the same condition, open and under way.
- 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
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035516
- Sponsor's protocol ID
- CA163-011
- Status last verified
- Feb 2016
- First submitted
- 3 May 2002
- Last updated
- 10 Feb 2016
- Results posted
- No
Publications
Vansteenkiste J, Lara PN Jr, Le Chevalier T, Breton JL, Bonomi P, Sandler AB, Socinski MA, Delbaldo C, McHenry B, Lebwohl D, Peck R, Edelman MJ. Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy. J Clin Oncol. 2007 Aug 10;25(23):3448-55. doi: 10.1200/JCO.2006.09.7097. Epub 2007 Jul 2.
PubMed 17606973
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. 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 Non-Small Cell Lung Cancer Who Have Failed First Line Platinum Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00035516
- Acronym / sponsor ID
- CA163-011
- Conditions
- Carcinoma, Non-small-cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 6 May 2002 (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.
The purpose of this clinical research study is to learn if BMS-247550 can shrink or slow the growth of the cancer in patients with non-small cell lung cancer who have failed first-line platinum based chemotherapy. The safety of this treatment will also be studied.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed non-small cell lung cancer
- Bidimensionally measurable disease
- Progressed following therapy with one prior cisplatin or carboplatin based chemotherapy regimen for Stage III or IV or metastatic recurrent disease
- Adequate hematologic function as defined by: absolute neutrophils =/> 2,000/mm3, and platelets > 125,000/mm3
- Adequate hepatic function as defined by: serum bilirubin=/<1.5 times the upper institutional limits of normal, ALT =/< 2.5 times the upper institutional limits of normal (=/<5 times the upper institutional limits of normal if hepatic metastases are present
Key exclusion criteria (10 listed)
- More than one prior chemotherapy regimen for Stage IIIB or IV or for metastatic recurrent disease. Prior adjuvant or neoadjuvant chemotherapy is allowed.
- Patients who are candidates for curative resection.
- CTC Grade 2 or greater neuropathy (motor or sensory)
- Known brain metastases
- Prior radiation must have not included major bone marrow containing areas (pelvis, lumbar, spine) and must not have contained a target lesion as the only measurable lesion. A recovery period of at least 3 weeks after completion of radiotherapy is required prior to enrollment.
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 |
|---|---|---|
| Epothilone | 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 10 Feb 2016.
- Background: PubMed 17606973Vansteenkiste J, Lara PN Jr, Le Chevalier T, Breton JL, Bonomi P, Sandler AB, Socinski MA, Delbaldo C, McHenry B, Lebwohl D, Peck R, Edelman MJ. Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy. J Clin Oncol. 2007 Aug 10;25(23):3448-55. doi: 10.1200/JCO.2006.09.7097. Epub 2007 Jul 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epothilone in people with Carcinoma, Non-small-cell Lung, run by R-Pharm at 16 sites 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?
The sponsor lists 14 inclusion and 10 exclusion criteria. 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 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
On the ClinicalTrials.gov record for NCT00035516, which also lists 1 linked publication.
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 10 Feb 2016.