Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00110084
First received: May 3, 2005
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Gemcitabine
Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Proportion of Patients With Confirmed Responses [ Time Frame: Two consecutive evaluations at least 6 weeks apart ] [ Designated as safety issue: No ]

    Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.

    Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.



Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Time from registration to progression or death (up to 5 years) ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.

  • Overall Survival [ Time Frame: Death or last follow-up (up to 5 years) ] [ Designated as safety issue: No ]
    Overall survival time was defined as the number of days from registration to the date of death or last follow-up

  • Adverse Event [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
    Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0


Enrollment: 50
Study Start Date: August 2005
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nab-paclitaxel/Gemcitabine Drug: Gemcitabine
1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Other Name: Gemzar
Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Other Name: nab (nanoparticle albumin-bound)-Paclitaxel, Abraxane

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110084

  Show 201 Study Locations
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Vivek Roy, MD, FACP Mayo Clinic
Study Chair: Philip J. Stella, MD CCOP - Michigan Cancer Research Consortium
Principal Investigator: Tom R. Fitch, M.D. Mayo Clinic
Principal Investigator: Timothy J. Hobday, M.D. Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Vivek Roy, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00110084     History of Changes
Other Study ID Numbers: CDR0000423195, U10CA025224, N0531, 855-05, N0433
Study First Received: May 3, 2005
Results First Received: March 29, 2011
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014