NCT00002937

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: Randomized phase II trial to compare the effectiveness of paclitaxel with or without PSC 833 in treating patients with metastatic breast cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jun 1996

Longer than P75 for phase_2 breast-cancer

Geographic Reach
2 countries

4 active sites

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

June 1, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

September 3, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

January 6, 2010

Status Verified

January 1, 2010

Enrollment Period

9.4 years

First QC Date

November 1, 1999

Last Update Submit

January 4, 2010

Conditions

Breast Cancer

Keywords

recurrent breast cancer

Interventions

paclitaxelDRUG
valspodarDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Metastatic breast cancer within 2 years of an adjuvant anthracycline based chemotherapy for advanced disease, or failure of one prior anthracycline based chemotherapeutic regimen for advanced breast cancer Exception: When anthracyclines are contraindicated, metastatic disease within 2 years of any adjuvant cytotoxic regimen, or failure of one prior cytotoxic chemotherapeutic regimen for advanced breast cancer also qualifies Evaluable or measurable disease in at least one nonirradiated area No CNS metastases PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 8.0 g/dL Absolute neutrophil count at least 1500/mm3 Hepatic: Total serum bilirubin no greater than 1.5 mg/dL No history of chronic active hepatitis or cirrhosis SGOT and/or SGPT no greater than 2 times the upper limit of normal Renal: Serum creatinine no greater than 2.0 mg/dL Other: Not HIV positive Not pregnant or nursing Effective contraceptive required of fertile patients No uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or bowel obstruction No history of a second malignancy with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix No known hypersensitivity to ingredients of the study medication or cyclosporine No neurologic problems requiring treatment No treatment with drugs within 48 hours that are known to interact with cyclosporine PRIOR CONCURRENT THERAPY: At least 4 weeks since any investigational therapy Biologic therapy: No concurrent antibiotics, e.g. clarithromycin, erythromycin, nafcillin, rifampin, itraconazole, ketoconazole, or fluconazole (no greater than 200 mg/day allowed) Chemotherapy: No prior paclitaxel At least 6 weeks since nitrosoureas At least 4 weeks since other myelosuppressive chemotherapy Endocrine therapy: At least 2 weeks since hormone therapy No concurrent danazol Radiotherapy: At least 3 weeks since radiation therapy Surgery: Must be recovered from previous surgery Other: No concurrent calcium channel blockers, e.g. diltiazem, nicardipine, and verapamil No concurrent anticonvulsants, e.g. carbamazepine, phenobarbital, and phenytoin No concurrent bromocriptine

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

Sponsors & Collaborators

Study Sites (4)

Beckman Research Institute, City of Hope

Duarte, California, 91010, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxelvalspodar

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • James H. Doroshow, MD

    City of Hope Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 3, 2004

Study Start

June 1, 1996

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

January 6, 2010

Record last verified: 2010-01

Locations

US(3)CA(1)