Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alvocidib

Criteria

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