Status:
COMPLETED
ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by kil...
Detailed Description
OBJECTIVES: Primary * Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer. * Determine the toxicity profile of this regimen,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive breast cancer
- \- Clinical evidence of metastatic disease
- \+ No bone metastases or other non-measurable disease as the only evidence of metastasis
- Measurable disease, defined as at least 1 measurable lesion
- \- The following are considered non-measurable disease:
- Small lesions (\< 2 cm)
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusions
- Inflammatory breast disease
- Lymphangitis cutis or pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- HER2(human epidermal growth factor receptor 2)-positive disease allowed provided patient has received prior treatment with trastuzumab
- No evidence of active brain metastasis, including leptomeningeal involvement
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over Sex
- Female Menopausal status
- Not specified Performance status
- ECOG 0-1 Life expectancy
- At least 12 weeks Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN Renal
- Creatinine ≤ 1.5 mg/dL Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- No pre-existing peripheral neuropathy \> grade 1
- No other clinically significant illness or significant medical condition that would preclude study participation
- No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or agents that are chemically similar to study drugs
- No serious medical risk factors involving any of the major organ systems that would preclude study participation
- No active stage III or IV invasive non-breast malignancy within the past 5 years
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics Chemotherapy
- No more than 1 prior adjuvant chemotherapy regimen
- No prior chemotherapy for metastatic disease
- At least 6 months since prior adjuvant or neoadjuvant taxane
- More than 2 weeks since prior cytotoxic chemotherapy
- Prior neoadjuvant chemotherapy allowed
- No other concurrent chemotherapy Endocrine therapy
- Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed Radiotherapy
- Prior radiotherapy to target lesion allowed provided there is evidence of disease progression after completion of treatment
- More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target lesion only or single-dose palliative radiotherapy
- No concurrent radiotherapy Surgery
- Not specified Other
- More than 2 weeks since prior investigational drugs
- No concurrent participation in another clinical trial that is studying investigational procedures or therapies
- Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation of pain or lytic lesions from breast cancer
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00110084
Start Date
August 1 2005
End Date
August 1 2010
Last Update
June 2 2011
Active Locations (201)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
2
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
3
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
4
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019