BMS-247550 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy

• ClinicalTrials.gov Identifier: NCT00004927
• Recruitment Status: Completed
• First Posted: June 4, 2004
• Last Update Posted: January 30, 2017
• Sponsor: R-Pharm
• Collaborators: National Cancer Institute (NCI); Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): R-Pharm

Study Description

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have advanced solid tumors that have not responded to previous therapy.

Condition or disease	Intervention/treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: ixabepilone	Phase 1

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicities, safety, and a recommended phase II dose of BMS-247550 administered as a 1 hour infusion every 3 weeks in patients with advanced solid tumors. II. Evaluate the plasma pharmacokinetics of this drug in this patient population. III. Determine any preliminary evidence of antitumor activity of this drug in these patients.

OUTLINE: This is a dose escalation study. Patients receive BMS-247550 IV over 1 hour every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 8-12 months.

Study Design

• Study Type: Interventional (Clinical Trial)
• Primary Purpose: Treatment
• Official Title: Phase I Study of BMS-247550 Given Every Three Weeks in Patients With Advanced Malignancies
• Study Start Date: July 1999
• Actual Primary Completion Date: October 2002
• Actual Study Completion Date: October 2002

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor that has failed standard therapy or for which no standard therapy exists No hematological malignancies allowed Measurable or evaluable disease Must have clinical or radiological evidence of disease No active brain metastases including evidence of cerebral edema by CT or MRI, or progression from prior imaging study, any requirement for steroids, or clinical symptoms of/from brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No preexisting peripheral neuropathy greater than grade 1 due to any cause No documented hypersensitivity reaction grade 2 or greater to prior paclitaxel or other therapy containing Cremophor EL No serious uncontrolled medical disorder or active infection that would preclude protocol therapy No dementia or altered mental status that would preclude compliance HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and doxorubicin HCl liposome) Prior taxanes allowed No more than 2 prior chemotherapy regimens in metastatic setting Prior adjuvant/neoadjuvant chemotherapy allowed No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy (except hormone replacement therapy or medication to maintain castrate status) Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy Surgery: No concurrent surgery Other: At least 4 weeks since other prior investigational agents No other concurrent experimental anticancer medications No other concurrent specific antitumor therapy

Contacts and Locations

Locations

United States, Michigan

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

United States, New York

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10021

Sponsors and Collaborators

R-Pharm

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Investigators

• Study Chair: David R. Spriggs, MD; Memorial Sloan Kettering Cancer Center

More Information

Publications of Results:

Aghajanian C, Burris HA 3rd, Jones S, Spriggs DR, Cohen MB, Peck R, Sabbatini P, Hensley ML, Greco FA, Dupont J, O'Connor OA. Phase I study of the novel epothilone analog ixabepilone (BMS-247550) in patients with advanced solid tumors and lymphomas. J Clin Oncol. 2007 Mar 20;25(9):1082-8. Epub 2007 Jan 29.

• Responsible Party: R-Pharm
• ClinicalTrials.gov Identifier: NCT00004927
• Other Study ID Numbers: BMS-CA163-001; MSKCC-99052; CDR0000067611 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-87; NCI-G00-1698; MAYO-C2072
• First Posted: June 4, 2004
• Last Update Posted: January 30, 2017
• Last Verified: January 2017

Keywords provided by R-Pharm:

unspecified adult solid tumor, protocol specific