Hormone Blockade in Combination With Targeted Agents
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01197170
First received: September 7, 2010
Last updated: April 8, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Sirolimus
Anastrozole
Everolimus
Temsirolimus
Erlotinib hydrochloride
Erlotinib
Bevacizumab
Sorafenib
Sorafenib tosylate
U.S. FDA Resources
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: | 162 |
| 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:
|
|
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:
|
|
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:
|
|
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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- Measurable or non-measurable disease
- Patients must have tumors that demonstrate ER/PR+ (positivity by IHC staining >/= 1%).
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2
- 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.
- 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.
- Ability to understand and the willingness to sign a written informed consent document
- 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:
- 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.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg on medication).
- Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
- Women who are pregnant or breastfeeding
- Patients with a history of bone marrow transplant within the previous two years.
- Patients with a known hypersensitivity to any of the components of the drug products.
- Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
- Patients with major surgery within 30 days prior to entering the study.
- 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 |
| Study First Received: | September 7, 2010 |
| Last Updated: | April 8, 2013 |
| 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 May 16, 2013