Hormone Blockade in Combination With Targeted Agents

This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01197170
First received: September 7, 2010
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

The goal of this clinical research study to find the highest tolerated dose of anastrozole alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied.


Condition Intervention Phase
Solid Tumors
Advanced Cancer
Drug: Anastrozole
Drug: Bevacizumab
Drug: Everolimus
Drug: Sorafenib
Drug: Erlotinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: Every 28 day cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 281
Study Start Date: September 2010
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anastrozole
1 mg PO (by mouth) daily for 28 days.
Drug: Anastrozole
1 mg by mouth daily of a 28 day cycle.
Other Name: Arimidex
Experimental: Anastrozole + Bevacizumab
Anastrozole 1 mg PO daily and Bevacizumab starting dose 10 mg IV Day 1 of 21 day cycle. Expansion group added when MTD dose of Anastrozole + Bevacizumab found.
Drug: Anastrozole
1 mg by mouth daily of a 28 day cycle.
Other Name: Arimidex
Drug: Bevacizumab
Starting dose 10 mg by vein on day 1 of a 21 day cycle.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAB-VEGF
Experimental: Anastrozole + Everolimus
Anastrozole 1 mg PO daily and Everolimus starting dose 5 mg PO daily for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Everolimus found.
Drug: Anastrozole
1 mg by mouth daily of a 28 day cycle.
Other Name: Arimidex
Drug: Everolimus
Starting dose 5 mg by mouth daily for a 28 day cycle.
Other Names:
  • Afinitor
  • RAD001
Experimental: Anastrozole + Sorafenib
Anastrozole 1 mg PO daily and Sorafenib starting dose 200 mg PO twice a day for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Sorafenib found.
Drug: Anastrozole
1 mg by mouth daily of a 28 day cycle.
Other Name: Arimidex
Drug: Sorafenib
Starting dose 200 mg by mouth twice a day of a 28 day cycle.
Other Names:
  • Nexavar
  • BAY43-9006
Experimental: Anastrozole + Erlotinib
Anastrozole 1 mg PO daily and Erlotinib starting dose 75 mg PO daily for 28 day cycle. Expansion group added when MTD dose of Anastrozole + Erlotinib found.
Drug: Anastrozole
1 mg by mouth daily of a 28 day cycle.
Other Name: Arimidex
Drug: Erlotinib
Starting dose 75 mg by mouth daily for a 28 day cycle.
Other Names:
  • OSI-774
  • Tarceva

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have had no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
  2. Measurable or non-measurable disease
  3. Patients must have tumors that demonstrate ER/PR+ (positivity by IHC staining >/= 1%).
  4. At least 4 weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (Exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least 6 weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least 4 weeks (or 5 half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2
  6. Patients must have normal organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/= 50,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 5 X ULN.
  7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
  8. Ability to understand and the willingness to sign a written informed consent document
  9. Female patients must either be: Post-menopausal women as defined by a. age >/= 60 years of age; b. prior bilateral oophorectomy; c. age < 60 with at least 12 months of spontaneous amenorrhea or post-menopausal range FSH and estradiol levels OR Premenopausal women receiving a gonadotropin-releasing hormone agonist.

Exclusion Criteria:

  1. Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results.
  2. Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg on medication).
  3. Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
  4. Women who are pregnant or breastfeeding
  5. Patients with a history of bone marrow transplant within the previous two years.
  6. Patients with a known hypersensitivity to any of the components of the drug products.
  7. Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
  8. Patients with major surgery within 30 days prior to entering the study.
  9. Age under 18 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197170

Contacts
Contact: Jennifer J. Wheler, MD 713-563-1930

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jennifer J. Wheler, MD    713-563-1930      
Principal Investigator: Jennifer J. Wheler, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jennifer J. Wheler, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01197170     History of Changes
Other Study ID Numbers: 2010-0504, NCI-2012-01794
Study First Received: September 7, 2010
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hormonal therapies
Estrogen receptor
Progesterone receptor
Hormone blockade
Hormone-positive tumors
Advanced cancer
Metastatic cancer
Avastin
Anti-VEGF monoclonal antibody
rhuMAB-VEGF
Afinitor
RAD001
Nexavar
BAY43-9006
OSI-774
Tarceva

Additional relevant MeSH terms:
Neoplasms
Antibodies
Antibodies, Monoclonal
Everolimus
Sirolimus
Hormones
Anastrozole
Bevacizumab
Sorafenib
Erlotinib
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014