Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Avon Foundation
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00983424
First received: September 22, 2009
Last updated: September 13, 2013
Last verified: September 2013

September 22, 2009
September 13, 2013
February 2010
May 2013   (final data collection date for primary outcome measure)
  • To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC). [ Time Frame: labs drawn weekly ] [ Designated as safety issue: Yes ]
  • To determine the maximum-tolerated dose (MTD) of Cyclosporine A and nab-paclitaxel in patients. [ Time Frame: at study completion (estimated at 2 years) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00983424 on ClinicalTrials.gov Archive Site
To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients. [ Time Frame: every 6-8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer
A Phase I, Open-label, Study of the Safety and Tolerability of Cyclosporine A (CsA) in Combination With Nab-paclitaxel in Patients With Metastatic Breast Cancer

The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone.

Treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug nab-paclitaxel. Nab-paclitaxel is a special preparation of paclitaxel inside a protein layer of albumin. Other studies have shown Cyclosporine A (CsA) may block the progression of advanced breast cancer. The combination of nab-paclitaxel and CsA is considered investigational which means it has not been approved by the US Food and Drug Administration, FDA. Participants on this study will receive nab-paclitaxel through a vein in the arm weekly 3 weeks out of 4, in the outpatient clinic. On the same day as the first infusion of nab-paclitaxel, participants will begin taking CsA tablets twice a day by mouth. Participants will continue to receive study treatment as long as their tumor responds. If the tumor does not respond or the participant experience severe side effects from study treatment, she will be removed from the study and offered other therapies, if that is appropriate.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Cyclosporins
    dose escalation, administered orally twice a day
    Other Names:
    • Neoral
    • Gengraf
  • Drug: nab-paclitaxel
    100 mg/m2 IV days 1, 8 and 15
Experimental: Treatment arm
Cyclosporine A + nab-paclitaxel
Interventions:
  • Drug: Cyclosporins
  • Drug: nab-paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Female or male patients with adenocarcinoma of the breast with metastatic disease.
  • Patients may have evaluable or measurable disease.
  • Age > 18 years.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Able to swallow and retain oral medication.

Exclusion Criteria

  • Patients who have had any major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Prior nab-paclitaxel is allowed.
  • Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.
  • Patients with uncontrolled brain metastases or leptomeningeal disease or active neurologic impairment.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cyclosporine A or nab-paclitaxel.
  • Pregnant or lactating (Cyclosporine A is excreted into breast milk) females
  • Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
  • HIV-positive patients are excluded since Cyclosporine A may result in further immunosuppression
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00983424
NU 08B7, STU00015585, NCI-2011-00223
Yes
Northwestern University
Northwestern University
Avon Foundation
Principal Investigator: William Gradishar, MD Northwestern University
Northwestern University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP