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

Phase 2

Completed

• Conditions: Stage IV Renal Cell Cancer; Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer
• Interventions: Drug: ixabepilone; Other: laboratory biomarker analysis

• Registration Number: NCT00182702
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Primary Completion: 2007-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-03-22
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	laboratory biomarker analysis	Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment	ixabepilone	Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective response rate (partial or complete)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From the start of treatment to time of progression, assessed up to 5 years	PFS rate will be estimated using the Kaplan-Meier method. Median PFS time and its associated 90% confidence interval will be estimated using the method of Brookmeyer and Crowley.
Overall survival (OS)	Up to 5 years	OS rate will be estimated using the Kaplan-Meier method. Median OS time and its associated 90% confidence interval will be estimated using the method of Brookmeyer and Crowley.

Trial Locations

Locations (1)

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States