Status:
TERMINATED
A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer
Lead Sponsor:
Celgene
Conditions:
Stage IV (Metastatic) Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granuloc...
Eligibility Criteria
Inclusion
- Patient has microscopically confirmed invasive breast carcinoma with clinical and/or radiographic evidence of stage 4 disease. If diagnosis is based on pleural effusion, positive cytology must be confirmed.
- Patient has had no prior chemotherapy for Stage 4 disease (hormone therapy is permitted). Prior adjuvant paclitaxel by 3-hour infusion is permitted, if there is no residual neuropathy. Prior adjuvant docetaxel on an every 3 week schedule is permitted.
- Disease must be measurable (unidimensional by Response Evaluation Criteria In Solid Tumors (RECIST) criteria) or evaluable (e.g., malignant effusion, marrow involvement). Elevated tumor markers alone are insufficient.
- Age \>18.
- Southwest Oncology Group (SWOG)/Eastern Oncology Group (ECOG) performance status must be \< or =2 at screen and on treatment day one.
- Life expectancy must be estimated at \>16 weeks.
- Prior irradiation is permitted, provided:
- Does not exceed 25% of the estimated bone marrow volume
- Measurable/evaluable disease exists outside the radiation field, or progressive disease is documented within the radiation field.
- Informed consent must be obtained prior to registration.
- Patients must be \> 2 weeks from prior surgery; \> 3 weeks from radiation therapy to the pelvis, spine or long bones; \> 3 weeks from prior chemotherapy (\> 6 weeks for mitomycin C or nitrosureas), or \> 2 weeks from prior hormonal therapy.
- All patients must have placement of appropriate central venous access device.
- Tumor HER2/neu expression must be determined prior to study enrollment. Assessment may be by fluorescence in situ hybridization (FISH) assay or by immunohistochemistry (ICC). If determination is intermediate by ICC, FISH must be performed. For enrollment purposes, this phase I study will not discriminate based on HER2 status. However, documentation of patients' HER2 status will be maintained and Herceptin will be prescribed for all HER2 positive patients.
Exclusion
- Granulocytes \< 1,500/mm\^3.
- Platelets \< 100,000/mm\^3.
- Hemoglobin \< 9 gm/dl.
- Creatinine \> 2.0 mg/dl.
- Total bilirubin \> 2 mg/dl.
- Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases.
- Medically unstable as judged by the patient's physician.
- Pregnancy or lactation; failure to employ adequate contraception.
- Uncontrolled central nervous system (CNS) disease.
- Pre-existing Grade ≥ 2 peripheral neuropathy except for abnormalities due to cancer.
- Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.
- Prior therapy with vinorelbine or prior therapy with a taxane that resulted in neuropathy.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00140140
Start Date
August 1 2005
End Date
February 1 2008
Last Update
November 26 2019
Active Locations (2)
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1
City of Hope Comprehensive Cancer Care Center
Duarte, California, United States, 91010
2
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109