ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer

Mayo Clinic

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Gemcitabine

Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00110084

N0433 (Other Identifier)

N0531 (Other Identifier)

855-05 (Other Identifier)

CDR0000423195

U10CA025224 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.

Full 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, in terms of incidence and severity of observed toxic effects, in these patients.

Secondary

* Determine the time to disease progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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