NCT00003690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Dec 1998

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

August 3, 2011

Status Verified

August 1, 2011

Enrollment Period

4.8 years

First QC Date

November 1, 1999

Last Update Submit

August 2, 2011

Conditions

Breast CancerMelanoma (Skin)Prostate CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV breast cancerrecurrent breast cancerstage IV prostate cancerrecurrent prostate cancerstage IV melanomarecurrent melanomaunspecified adult solid tumor, protocol specific

Interventions

alvocidibDRUG
carboplatinDRUG
cisplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMelanomaProstatic Neoplasms

Interventions

alvocidibCarboplatinCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Keith C. Bible, MD, PhD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

December 1, 1998

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

August 3, 2011

Record last verified: 2011-08

Locations

US(1)