Ixabepilone in Treating Patients With Renal Cell Carcinoma (Kidney Cancer) - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00033670

Purpose

RATIONALE: Drugs used in chemotherapy, such as ixabepilone (BMS-247550), work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with renal cell carcinoma (kidney cancer).

Condition	Intervention	Phase
Kidney Cancer	Drug: ixabepilone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Clinical Trial Of BMS-247550 (NSC 710428), an Epothilone B Analog, in Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Ixabepilone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Activity [ Designated as safety issue: No ]
Plasma pharmacokinetics and pharmacodynamics [ Designated as safety issue: No ]
Nerve growth factor (NGF) levels [ Designated as safety issue: No ]
Correlation of NGF levels with neurotoxicity [ Designated as safety issue: Yes ]
Differences between responding and non-responding tumors as assessed by cDNA microarray [ Designated as safety issue: No ]

Estimated Enrollment:	114
Study Start Date:	February 2002
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the activity of ixabepilone in patients with renal cell carcinoma.
Determine the plasma pharmacokinetics and pharmacodynamics of this drug using an assay that measures the relative amounts of polymerized versus unpolymerized endogenous tubulin in peripheral blood mononuclear cells of these patients.
Determine the nerve growth factor (NGF) levels in patients before and after receiving this drug.
Determine the correlation (if any) between NGF levels in these patients and neurotoxicity of this drug.
If this drug is found to be active in more than 20% of these patients, determine whether differences exist between responding and non-responding tumors by analyzing tumor samples using cDNA microarray.

Secondary

Determine the extent to which pharmacodynamic changes are observed over a range of doses of ixabepilone.
Determine if cross-resistance to ixabepilone exists in patients who have received prior sorafenib or sunitinib.

OUTLINE: Patients are stratified according to histologic subtype (clear cell vs type I or II papillary vs chromophobe, collecting duct, or medullary).

Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36-114 patients (12-74 per stratum) will be accrued for this study within 7-48 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed renal cell carcinoma
- Eligible subtypes:
  - Clear cell
  - Type I or II papillary
  - Chromophobe
  - Collecting duct
  - Medullary
Received prior, ineligible for, or refused interleukin-2
Measurable disease
No prior CNS metastases unless control was achieved with radiotherapy or surgical resection at least 6 months before study entry
Must meet 1 of the following criteria:
- Received sorafenib and/or sunitinib and had progressive disease while receiving the drugs
- Evaluated for therapy with sorafenib and/or sunitinib and deemed to be ineligible
- Evaluated for therapy with sorafenib and/or sunitinib and refused treatment

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 3 months

Hematopoietic:

Platelet count at least 100,000/mm^3
Absolute granulocyte count at least 1,500/mm^3

Hepatic:

Bilirubin no greater than 1.5 times normal (3 times normal if clinical evidence of Gilbert's disease)
SGPT and SGOT no greater than 2.5 times normal

Renal:

Creatinine no greater than 1.6 mg/dL OR
Creatinine clearance at least 40 mL/min

Other:

HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study completion
No other serious concurrent medical illness
No active, uncontrolled infection
No other nonmalignant systemic disease that would preclude study participation
No grade 2 or greater motor or sensory neuropathy
No prior hypersensitivity reactions to agents containing Cremophor EL

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics
At least 4 weeks since prior immunotherapy
Prior thalidomide allowed

Chemotherapy:

At least 4 weeks since prior cytotoxic chemotherapy
No other prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior craniospinal or total body irradiation
At least 4 weeks since other prior radiotherapy

Surgery:

See Disease Characteristics

Other:

No other concurrent investigational drugs
No concurrent Hypericum perforatum (St. John's Wort)
At least 2 weeks since prior targeted-therapy (cytostatic agents) and recovered

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033670

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Antonio T. Fojo, MD, PhD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NCI - Cancer Therapeutics Branch ( Antonio Tito Fojo )
Study ID Numbers:	CDR0000069310, NCI-02-C-0130, NCI-3654
Study First Received:	April 9, 2002
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00033670 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer

stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Epothilones
Mitosis Modulators
Urogenital Neoplasms
Antimitotic Agents
Urologic Neoplasms
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Tubulin Modulators
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009