Ixabepilone in Treating Patients With Metastatic, Recurrent, or Unresectable Kidney Cancer

NCT ID: NCT00182702

Last Updated: 2013-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31

Brief Summary

This phase II trial is studying how well ixabepilone works in treating patients with metastatic, recurrent, or unresectable kidney cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with metastatic, recurrent, or unresectable renal cell carcinoma treated with ixabepilone.

SECONDARY OBJECTIVES:

I. Determine the progression-free and overall survival rates in patients treated with this drug.

II. Determine the toxicity of this drug in these patients. III. Correlate VHL gene mutations with response in patients treated with this drug.

IV. Correlate VHL pathway protein expression with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 9 weeks until disease progression and then every 3 months for up to 2 years.

Conditions

Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

ixabepilone

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

BMS-247550; epothilone B lactam; Ixempra

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed renal cell carcinoma of 1 of the following subtypes:

• Clear cell
• Papillary, type I or II
• Chromophobe
• Collecting duct
• Medullary
• Metastatic, recurrent, or unresectable disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No known active brain metastases requiring steroid or anticonvulsant therapy

• Patients with definitively treated brain metastases are eligible provided they are not on steroids or anticonvulsants AND show no evidence of disease progression for ≥ 3 months after completion of definitive therapy
• Performance status - ECOG 0-2
• At least 3 months
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Glomerular filtration rate ≥ 50 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No ongoing or active infection
• No HIV positivity
• No peripheral neuropathy > grade 1
• No psychiatric illness or social situation that would preclude study compliance
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
• No history of severe hypersensitivity reaction to agents containing Cremophor® EL
• No other active malignancy

• Curatively treated malignancies are allowed provided the risk of recurrent disease at the time of study enrollment is < 20%
• No other uncontrolled illness
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No prior tubule inhibitors, including, but not limited to, any of the following:

• Vinca alkaloids (e.g., vinblastine, vincristine, or vinorelbine)
• Taxanes (e.g., docetaxel or paclitaxel)
• Epothilones
• No other concurrent chemotherapy
• See Disease Characteristics
• No concurrent hormonal therapy except steroids for adrenal failure or hypersensitivity prophylaxis or hormones for non-disease related conditions (e.g., insulin for diabetes)
• More than 4 weeks since prior radiotherapy and recovered
• No concurrent palliative radiotherapy
• No other concurrent investigational agents
• No other concurrent anticancer therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edwin Posadas

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Comprehensive Cancer Center

Locations

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

13850A

Identifier Type: -

Identifier Source: secondary_id

N01CM62201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000440071

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02669

Identifier Type: -

Identifier Source: org_study_id