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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

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

Treatments: Other: laboratory biomarker analysis; Drug: ixabepilone

Study type: Interventional

Funder types: NIH

Identifiers

NCT00182702

13850A

CDR0000440071 (Registry Identifier)

N01CM62209 (U.S. NIH Grant/Contract)

N01CM62201 (U.S. NIH Grant/Contract)

NCI-2012-02669

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Treatment

Experimental group

Description:

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:

Drug: ixabepilone

Other: laboratory biomarker analysis