NCT00724386

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jun 1999

Longer than P75 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

June 1, 1999

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

6.3 years

First QC Date

July 25, 2008

Last Update Submit

March 6, 2014

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • feasibility of administering study therapy to limit skin toxicity

    4 weeks

  • dose-limiting toxicity

    4 weeks

Secondary Outcomes (4)

  • response

    14 weeks

  • time to progression

  • overall survival

  • Bcl-2 detection by immunohistochemistry

    14 weeks

Interventions

PaclitaxelDRUG

1-hour IV infusion once weekly for 12 to 14 weeks

Also known as: Taxol
VinorelbineDRUG

escalating doses administered intravenously over 6-10 minutes for 12-14 weeks

Also known as: Navelbine
FilgrastimDRUG

daily injections for 6 days beginning on day 2 of second week on study and then every other week (weeks 2, 4, 6, 8, 12). For the final dose cohort, administration on chemotherapy only weeks, only if dose reduction or dose delay required by subject

RadiationRADIATION

Radiotherapy for 5 consecutive days every other week (weeks 1, 3, 5, 7, 9, 11, 13)starting on same day as first dose of protocol chemotherapy

Eligibility Criteria

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

You may qualify if:

  • 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:
  • patients with locally advanced unresectable stage IIIa or IIIb;
  • patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
  • 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)
  • 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
  • Initial Laboratory Data:
  • ANC Count \> 1500/mm3
  • Platelet Count \> 100,000/mm3
  • Creatine ≤ 2.0 mg/dl
  • Bilirubin ≤ 1.5 mg/dl
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PaclitaxelVinorelbineFilgrastimRadiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhysical Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

June 1, 1999

Primary Completion

October 1, 2005

Study Completion

November 1, 2012

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

US(1)