Clinical trial NCT00724386: Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-07-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
* 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

Primary outcomes:
measure: feasibility of administering study therapy to limit skin toxicity
timeFrame: 4 weeks
measure: dose-limiting toxicity
timeFrame: 4 weeks
Secondary outcomes:
measure: response
timeFrame: 14 weeks
measure: time to progression
measure: overall survival
measure: Bcl-2 detection by immunohistochemistry
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References: