NCT00016939
Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
PHASE2
COMPLETED
NCT00016939
INTERVENTIONAL
A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable
* Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field
* No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* No hypercoagulable state other than renal cell cancer
Hepatic:
* Not specified
Renal:
* Not specified
Cardiovascular:
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No prior isolated occurrence of deep venous thrombosis within the past 6 months
Pulmonary:
* No prior isolated occurrence of pulmonary embolism within the past 6 months
Other:
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission
* No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I)
* No other uncontrolled illness (e.g., diabetes mellitus)
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* 1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed
* At least 28 days since prior immunotherapy and recovered
* No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
* No prior chemotherapy for renal cell cancer
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 21 days since prior radiotherapy and recovered
Surgery:
* See Disease Characteristics
* Prior resection of primary tumor allowed
* At least 28 days since prior surgery and recovered
Kidney Cancer
- TREATMENT
-
- Type: DRUG
- Name: alvocidib
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network