Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: alvocidib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer |
| Study Start Date: | May 2001 |
OBJECTIVES:
- Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol.
- Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in this patient population.
- Determine, in a preliminary manner, the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 101 Study Locations| Study Chair: | Peter J. VanVeldhuizen, MD | Kansas City Veteran Affairs Medical Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00016939 History of Changes |
| Other Study ID Numbers: | CDR0000068634, SWOG-S0109 |
| Study First Received: | June 6, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Flavopiridol Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Growth Inhibitors Growth Substances Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013