Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Indiana University
Collaborator:
Translational Breast Cancer Reserach Consortium
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00577122
First received: December 18, 2007
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate the impact of MPA alone and in combination with low dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Estrogen Receptor-negative Breast Cancer Progesterone Receptor-negative Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer |
Drug: Medroxyprogesterone progesterone acetate (MPA) Drug: Medroxyprogesterone with Cyclophosphamide + Methotrexate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients With Hormone Receptor Negative Breast Cancer. A Translational Breast Cancer Research Consortium (TBCRC) Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Progesterone
Methotrexate
Hydroxyprogesterone
Medroxyprogesterone acetate
Hydroxyprogesterone caproate
Methotrexate sodium
U.S. FDA Resources
Further study details as provided by Indiana University:
Primary Outcome Measures:
- To determine the clinical benefit rate (CR + PR + SD > 6 months) of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. [ Time Frame: baseline through end of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the toxicity of MPA and MPA + ldoCM in this patient population [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: Yes ]
- To explore the relationship between MPA trough level and clinical benefit [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: No ]
- To explore genetic determinants of MPA bioavailability and trough concentration [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: No ]
- To explore potential surrogates of biologic activity including Nm-23 expression in primary tumor, change in Nm-23 expression in skin, change in plasma TSP-1, change in plasma PAI-1 antigen and activity. [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort I (MPA)
Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
|
Drug: Medroxyprogesterone progesterone acetate (MPA)
1000 mg po daily
Other Names:
|
|
Experimental: Cohort II (MPA, low-dose chemotherapy)
Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose. Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week. |
Drug: Medroxyprogesterone with Cyclophosphamide + Methotrexate
Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the clinical benefit rate (complete response [CR] + partial response [PR] + stable disease [SD] >= 6 months) of medroxyprogesterone acetate (MPA) monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of MPA and MPA + ldoCM in this patient population. II. To explore the relationship between MPA trough level and clinical benefit. III. To explore genetic determinants of MPA bioavailability and trough concentration.
IV. To explore potential surrogates of biologic activity including Nm-23 expression in primary tumor, change in Nm-23 expression in skin, change in plasma thrombospondin (TSP)-1, change in plasma plasminogen activator inhibitor (PAI)-1 antigen and activity.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
COHORT I: Patients receive MPA orally (PO) once daily (QD).
COHORT II: Patients receive MPA as in Cohort I, cyclophosphamide PO QD, and methotrexate PO twice daily (BID) on days 1 and 2 of every week.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
- Primary tumor must be ER negative and PR negative
- Patients must be post-menopausal
- Patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease
- Adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol
- Patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required
Exclusion Criteria:
- Patients must not have extensive pleural effusion or ascites
- Patients must not have history of DVT or pulmonary embolism w/in past 12 mo
- Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry
- Patients must not have had radiation therapy within 1 week of study entry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577122
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| University of California, San Francisco Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, North Carolina | |
| University of North Carolina, Lineberger Comprehensive Cancer Center | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke University Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| The University of Texas M. D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Indiana University
Translational Breast Cancer Reserach Consortium
Investigators
| Principal Investigator: | Kathy Miller, MD | IU Simon Cancer Center |
More Information
No publications provided
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00577122 History of Changes |
| Other Study ID Numbers: | 0607-18 IUCRO-0154, TBCRC 007 |
| Study First Received: | December 18, 2007 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Medroxyprogesterone progesterone acetate (MPA) Cyclophosphamide plus Methotrexate |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Methotrexate Medroxyprogesterone Acetate 17-alpha-hydroxy-progesterone caproate 11-hydroxyprogesterone Progesterone Medroxyprogesterone Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Estradiol Antagonists Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013