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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724386
• Other study ID #: UCIRB 9849
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2008
• Last updated: March 6, 2014
• Start date: June 1999
• Est. completion date: November 2012

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2012
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Paclitaxel
1-hour IV infusion once weekly for 12 to 14 weeks
• Vinorelbine
escalating doses administered intravenously over 6-10 minutes for 12-14 weeks
• Filgrastim
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

Radiation:
• Radiation
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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of administering study therapy to limit skin toxicity		4 weeks	Yes
Primary	dose-limiting toxicity		4 weeks	Yes
Secondary	response		14 weeks	No
Secondary	time to progression		unknown	No
Secondary	overall survival		unknown	No
Secondary	Bcl-2 detection by immunohistochemistry		14 weeks	No