Clinical trial NCT00182702: Ixabepilone in Treating Patients With Metastatic, Recurrent, or Unresectable Kidney Cancer
Official title: A Phase II Trial of BMS 247550 (Ixabepilone) in Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-09-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate (partial or complete)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From the start of treatment to time of progression, assessed up to 5 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Edwin Posadas
role: PRINCIPAL_INVESTIGATOR
References: