Status:
COMPLETED
Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Amgen
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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)
- 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
- Initial Laboratory Data:
- ANC Count \> 1500/mm3
- Platelet Count \> 100,000/mm3
- Creatine ≤ 2.0 mg/dl
- Bilirubin ≤ 1.5 mg/dl
- ALT (SGPT) ≤ 3 times the upper limit of normal
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00724386
Start Date
June 1 1999
End Date
November 1 2012
Last Update
March 7 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637