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Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

A Phase I Study of Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine With Filgrastim Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

NCT00724386•University of Chicago

View on ClinicalTrials.gov

Summary

The goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine added to this combination when followed by Filgrastim and the dose-limiting toxicities of this regimen.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:
•1. patients with locally advanced unresectable stage IIIa or IIIb;
•2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
•3. patients with metastatic disease AND uncontrolled locoregional disease are eligible.
•Prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
•Prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
•4 weeks since any prior treatments (excluding hormonal therapy). Concurrent hormonal therapy is not allowed.
•Aged 18 years or older
•CALGB performance status of 0 - 2
•Life expectance of at least 12 weeks
+7 more criteria

Exclusion Criteria

•Prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
•Subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
•Patients with a documented hypersensitivity to E.coli derived proteins are excluded.
•No other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment

Locations (1)

University of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

June 1, 1999

Primary Completion Date

October 1, 2005

Completion Date

November 1, 2012

Last Updated

March 7, 2014

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Paclitaxel

DRUG

Vinorelbine

DRUG

Filgrastim

DRUG

Radiation

RADIATION

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RECRUITINGPHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer