The Impact of Obesity and Obesity Treatments on Breast Cancer

NCT00933309 | Completed Phase 1 DMC

• 1 other identifier: 2008-0284
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body.

Conditions

Breast Cancer

Keywords

Breast; Obese; Obesity Treatment; Exemestane; Aromasin; Metformin and Rosiglitazone; Avandamet; Postmenopausal; Hormone-sensitive; Hormone-receptive-positive breast cancer

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  Day 1 of each cycle

Study Arms (2)

Group 1

EXPERIMENTAL

Exemestane alone

Drug: Exemestane

Group 2

EXPERIMENTAL

Exemestane plus Avandamet

Drug: Exemestane; Drug: Avandamet

Interventions

Exemestane DRUG

25 mg tablets orally once a day

Also known as: Aromasin®

Group 1; Group 2

Avandamet DRUG

Beginning dose 2 mg rosiglitazone with 500 mg metformin hydrochloride (2mg/500 mg) tablets taken orally once a day

Also known as: Metformin plus rosiglitazone, Rosiglitazone and Metformin

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior endocrine therapy, biologic therapy and chemotherapy are allowed, either in the adjuvant setting or for metastatic breast cancer.
• Prior exemestane, metformin, or rosiglitazone is allowed if taken longer than 7 days prior to enrollment.
• Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of study medications.
• Performance status \</= 2 ECOG.
• Absolute neutrophil count (ANC) \>/= 1000/µl, platelets \>/= 75,000/µl, hemoglobin \>/= 8.5 gm/dL; serum creatinine \< 1.4 mg/dL; bilirubin \< 1.8 mg/dL; ALT or AST \</= 2.5 x ULN if no demonstrable liver metastases or \</= 5 x ULN in presence of liver metastases; alkaline phosphatase \< 3 x upper limit of normal; calcium \</= 11.0 mg/dL.
• Patients must be competent to give informed consent and to state that they understand the investigational nature of the proposed treatment.

You may not qualify if:

• Extensive radiotherapy within previous 4 weeks (greater than or equal to 30% of marrow-bearing bone, e.g., whole pelvis or half spine).
• Uncontrolled diabetes mellitus (hemoglobin A1C \> 9 or random plasma glucose \> 400 mg/dL).
• History of acromegaly, Cushing's syndrome, Cushing's disease, Addison's disease (treated or untreated).
• Patients with unstable angina, uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification).
• Concurrently receiving and are unwilling to discontinue hormonal (estrogen with or without progesterone) replacement therapy.
• Other investigational drugs within the past 3 weeks or concurrently.
• Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
• Laboratory results sustained at: International normalized ratio (INR) \> 1.6; ALT or AST \> 2.5 x ULN if no demonstrable liver metastases or \> 5 x ULN in presence of liver metastasis; No more than 3 retests within screening period
• Patients with known diagnosis of human immunodeficiency virus (HIV) infection.
• Patients who received chemotherapy within 3 weeks (6 weeks for nitrosourea or mitomycin-C). Acute toxicities from prior therapy must have resolved to Grade \</= 1 with the exception of fatigue, alopecia, or anemia.
• Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol e.g., severe renal or hepatic impairment or currently unstable or uncompensated respiratory or cardiac conditions.
• History of hypersensitivity to active or inactive excipients of the study medications - exemestane or metformin.
• Untreated or clinically unstable central nervous system involvement. A patient with adequately treated brain metastases would be eligible one month after completion of surgery and/or radiation therapy if she is clinically stable.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

exemestane; rosiglitazone-metformin combination; Metformin; Rosiglitazone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Francisco J. Esteva, MD, PhD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2009
• First Posted: July 7, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 19, 2016

Record last verified: 2012-08

Locations

US (1)