Status:
COMPLETED
PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Ovarian Cancer
Breast Cancer
Eligibility:
FEMALE
18-99 years
Phase:
EARLY_PHASE1
Brief Summary
Study involves surgery for cytoreduction or laparoscopy to determine if you are a candidate for tumor debulking or a tissue biopsy. Following this surgery you will receive chemotherapy. This study wil...
Eligibility Criteria
Inclusion
- All patients must have cytology/ biopsy proven diagnosis of a mullerian carcinoma, high clinical index of suspicion for ovarian cancer OR triple negative, BRCA mutated breast cancer.
- Patients may not have received prior treatment for breast or ovarian cancer.
- All patients must be of at least 18 years of age.
- ECOG Performance status must be 0,1 or 2.
- Patients must not have received a prior PARP inhibitor
- Adequate organ and marrow function as defined below:
- absolute neutrophil count \>/= 1500/mcL
- Platelets \> /= 100,000 /mcl
- Hemoglobin \>/= 8 g/dl
- Total bilirubin \</= 1.5 x the institutional ULN
- AST, ALT \</= 3 x the institutional ULN
- Creatinine \</= the institutional ULN
- Women of child-bearing 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 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Patients must be able to swallow and retain oral medications.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment. Subjects must have recovered from prior treatment-related to toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
- Brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lynparza or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04041128
Start Date
July 23 2019
End Date
June 15 2021
Last Update
March 20 2023
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390