NCT00724386CompletedPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- dose-limiting toxicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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 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
Outcomes
Primary Outcomes
dose-limiting toxicity
Time Frame: 4 weeks
feasibility of administering study therapy to limit skin toxicity
Time Frame: 4 weeks
Secondary Outcomes
- response(14 weeks)
- time to progression
- overall survival
- Bcl-2 detection by immunohistochemistry(14 weeks)
Investigators
Study Sites (2)
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