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

• Status: Completed
• Trial end date: 2021-01-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Anastrozole; Antibodies; Antibodies, Monoclonal; Bevacizumab; Erlotinib Hydrochloride; Everolimus; Hormones; Sirolimus; Sorafenib

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; creatininebilirubin

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.