Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

alvocidib

carboplatin

cisplatin

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, stage IV melanoma, recurrent melanoma, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed unresectable advanced solid tumor for which no standard therapy exists that is potentially curative or definitely capable of extending life expectancy Biopsy confirmation of recurrent tumors required, unless sole site of disease is inaccessible bony and/or pulmonary metastases Eligible solid tumors include, but not are limited to, prostate cancer, breast cancer, or melanoma No lymphoma No CNS metastases Patients with primary brain tumors are eligible if they are not receiving antiepileptic medication(s) but are receiving stable doses of corticosteroids Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: See Disease Characteristics At least 12 weeks Hematopoietic: WBC at least 3,500/mm^3 Absolute neutrophil count at least 1,700/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin within upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No history of angina Neurologic: No grade 2 or greater peripheral neuropathy No seizure disorder Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: More than 4 weeks since prior immunotherapy More than 4 weeks since prior biologic therapy No concurrent immunotherapy Chemotherapy: More than 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: More than 4 weeks since prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: See Disease Characteristics

Sites / Locations

Mayo Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003690

First Posted

November 1, 1999

Last Updated

August 2, 2011

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00003690

Brief Title

Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors

Official Title

Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

December 1998 (undefined)

Primary Completion Date

September 2003 (Actual)

Study Completion Date

September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of flavopiridol plus cisplatin or carboplatin in treating patients who have advanced solid tumors.

Detailed Description

OBJECTIVES: Determine the maximum tolerated dose (MTD) of flavopiridol and cisplatin in patients with advanced solid tumors. (Part 1) Determine the MTD of carboplatin when combined with flavopiridol in another group of patients with advanced solid tumors. (Part 2) Determine the toxic effects of these regimens in this patient population. Determine the objective clinical response in patients treated with this regimen. Determine the pharmacokinetics of these regimens in this patient population. OUTLINE: This is a dose-escalation study of flavopiridol and cisplatin (part 1), followed by a dose-escalation study of carboplatin (part 2). Part 1: Patients receive flavopiridol IV over 24 hours. Two weeks later, patients receive cisplatin IV over 2 hours immediately followed by flavopiridol IV over 24 hours. Treatment with cisplatin/flavopiridol continues every 3 weeks in the absence of unacceptable toxicity or disease progression. Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Cohorts of 3-6 patients receive escalating doses of flavopiridol and then cisplatin until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Part 2: Additional patients are accrued for part 2. Those patients receive carboplatin IV over 30 minutes immediately followed by flavopiridol IV over 24 hours. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of carboplatin until the MTD is determined. The MTD is defined as in part 1. PROJECTED ACCRUAL: Approximately 36-48 patients will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Melanoma (Skin), Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV breast cancer, recurrent breast cancer, stage IV prostate cancer, recurrent prostate cancer, stage IV melanoma, recurrent melanoma, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

alvocidib

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Type

Drug

Intervention Name(s)

cisplatin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed unresectable advanced solid tumor for which no standard therapy exists that is potentially curative or definitely capable of extending life expectancy Biopsy confirmation of recurrent tumors required, unless sole site of disease is inaccessible bony and/or pulmonary metastases Eligible solid tumors include, but not are limited to, prostate cancer, breast cancer, or melanoma No lymphoma No CNS metastases Patients with primary brain tumors are eligible if they are not receiving antiepileptic medication(s) but are receiving stable doses of corticosteroids Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: See Disease Characteristics At least 12 weeks Hematopoietic: WBC at least 3,500/mm^3 Absolute neutrophil count at least 1,700/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin within upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No history of angina Neurologic: No grade 2 or greater peripheral neuropathy No seizure disorder Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: More than 4 weeks since prior immunotherapy More than 4 weeks since prior biologic therapy No concurrent immunotherapy Chemotherapy: More than 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: More than 4 weeks since prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: See Disease Characteristics

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keith C. Bible, MD, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Breast Cancer, Melanoma (Skin), Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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