Clinical trial NCT00035516: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-small-cell Lung
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2002-05-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Exclusion Criteria

* 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
* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Sacramento
country: United States
facility: Un of California Davis Cancer Center
state: California
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Rush Presbyterian St Lukes ME
state: Illinois
city: Louisville
country: United States
facility: Consultants in Blood Disorders
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Cancer Institute
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Greenbaum Cancer Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri/Ellis Fischel Cancer Center
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock /Norris Cotton Cancer Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Chapel Hill
country: United States
facility: Unviversity of North Carolina
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Med School Div of Medical Oncology
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
References:
citation: 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.