NCT00020332

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/II trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2000

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

October 1, 2000

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

June 17, 2013

Status Verified

July 1, 2002

First QC Date

July 11, 2001

Last Update Submit

June 14, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancermale breast cancer

Interventions

alvocidibDRUG
docetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV adenocarcinoma of the breast * Phase I: * Evaluable disease allowed * Phase II: * At least 1 site of measurable disease * No bone metastasis as only site of disease * No carcinomatous meningitis or brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Male or female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No active coagulopathy requiring therapeutic anticoagulation Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * SGOT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * No Gilbert's disease Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * Left ventricular ejection fraction at least 50% without clinical signs or symptoms of heart failure * No uncontrolled hypertension (sustained systolic blood pressure (BP) greater than 180 mm Hg or diastolic BP greater than 100 mm Hg) * No uncontrolled cardiac arrhythmia * No myocardial infarction within the past year * No significant ischemia or valvular heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical or psychiatric condition that would increase risk * No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer * No grade 2 or greater peripheral neuropathy * No diabetes mellitus with a fasting blood sugar greater than 200 mg/dL * No active unresolved infection * No serious concurrent medical illness * No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior flavopiridol * Prior adjuvant chemotherapy for advanced disease allowed if within 6 months of diagnosis of metastatic disease * At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or 8 weeks for UCN-01) and recovered * Phase I: * Any number of prior chemotherapy regimens for metastatic carcinoma of the breast allowed * Phase II: * No more than 2 prior chemotherapy regimens for metastatic carcinoma of the breast Endocrine therapy: * Prior hormonal therapy in the metastatic or adjuvant setting allowed * At least 2 weeks since prior hormonal therapy and no evidence of disease improvement by radiography after therapy * Concurrent corticosteroids allowed if for study premedication or hypersensitivity reactions/adverse events Radiotherapy: * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent antineoplastic therapies * No other concurrent investigational drugs

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

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

alvocidibDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Antoinette R. Tan, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

October 1, 2000

Study Completion

March 1, 2003

Last Updated

June 17, 2013

Record last verified: 2002-07

Locations

US(1)