COMPLETED

Trial of Maintenance With Niraparib- Uterine Serous Carcinoma

Conditions

Endometrial Cancer Papillary Serous Endometrial Carcinoma Uterine Serous Carcinoma Endometrial Carcinoma Cancer of the Endometrium Niraparib uterine Cancer papillary serous uterine cancer serous uterine cancer Endometrial Recurrent Uterine Carcinoma platinum-sensitive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Uterine serous carcinoma (USC) accounts for up to 40% of endometrial cancer-related deaths. Patients with USC share many genomic and clinical characteristics with patients who has serous ovarian cancer. The objective of this study is to evaluate the efficacy of maintenance Niraparib regimen in patients with advanced or platinum sensitive recurrent uterine serous carcinoma. Additionally, the investigators aim to further describe the safety of this regimen. The investigators hypothesize that Niraparib maintenance will be a well-tolerated treatment and show significant response in patients with uterine serous carcinoma.

Official Title

Trial of Maintenance With Niraparib in Patients With Stage III, Stage IV or Platinum-sensitive Recurrent Uterine Serous Carcinoma

Quick Facts

Study Start:2019-12-30

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04080284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Female, age at least 18 years 2. ECOG performance status of \<2 3. Written voluntary informed consent 4. Histologically diagnosed Uterine Serous Carcinoma. 5. Patient must agree to undergo Foundation One testing. 6. Patient diagnosed with advanced stage USC including stage III, stage IV, or platinum-sensitive recurrent USC 7. If recurrent USC, patient must have platinum sensitive disease after initial treatment; defined as achieving a response (CR or PR) and disease progression \>6 months after completion of their last dose of platinum chemotherapy. 8. Patients eligible if receiving 1st or 2nd line chemotherapy for recurrence. 9. The patient must have achieved a partial, stable, or complete tumor response following the last chemotherapy (minimal of 3 cycles) regimen of physician choice chemotherapy indicating partial, stable, complete tumor response. 10. Patients must receive Niraparib maintenance within 12 weeks after completion of their final dose of chemotherapy regimen or within 14 weeks if received radiation therapy. CT Chest/Abd/Pelvis will be performed within 28 days of starting Niraparib. 11. Lesions can be non-measurable or measurable by RECIST 1.1 criteria. 12. Adequate organ function, defined as: 1. Absolute neutrophil count ≥ 1,500/μL 2. Platelets ≥ 100,000/μL 3. Hemoglobin ≥ 9 g/dL 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation 5. Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN 6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN 13. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy. 14. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment. 15. Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non childbearing potential. Non childbearing potential is defined as follows (by other than medical reasons): 1. ≥45 years of age and has not had menses for \>1 year Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 6.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. 2. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment. 3. Able to take oral medications.	* 1. Participant must not be simultaneously enrolled in any interventional clinical trial 2. Drainage of ascites during the last 2 cycles of last chemotherapy 3. Radiotherapy was given within 2 weeks encompassing \>20% of the bone marrow or any radiation therapy within one week prior to Day 1 of protocol therapy. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. 4. Persistent \>Grade 2 anemia, neutropenia, or thrombocytopenia from prior cancer therapy, that has persisted \> 4 weeks and was related to the most recent treatment. 5. Symptomatic uncontrolled brain or leptomeningeal metastases. 6. Known hypersensitivity to the components of Niraparib 7. Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery 8. Diagnosis, detection, or treatment of invasive cancer other than uterine cancer \</= 2 years prior to study enrollment (except basal or squamous cell carcinoma of the skin that has been definitively treated) 9. Patient considered a poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection. 10. Patients must not have received a transfusion within 4 weeks of the first dose of study treatment 11. Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy. 12. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) 13. Immunocompromised patients (splenectomy patients are allowed) 14. Patients with known active hepatitis disease 15. Prior treatment with a known PARP inhibitor 16. Patients noted to have MSI-H mutational burden.

Inclusion Criteria

Exclusion Criteria

1. Female, age at least 18 years
2. ECOG performance status of \<2
3. Written voluntary informed consent
4. Histologically diagnosed Uterine Serous Carcinoma.
5. Patient must agree to undergo Foundation One testing.
6. Patient diagnosed with advanced stage USC including stage III, stage IV, or platinum-sensitive recurrent USC
7. If recurrent USC, patient must have platinum sensitive disease after initial treatment; defined as achieving a response (CR or PR) and disease progression \>6 months after completion of their last dose of platinum chemotherapy.
8. Patients eligible if receiving 1st or 2nd line chemotherapy for recurrence.
9. The patient must have achieved a partial, stable, or complete tumor response following the last chemotherapy (minimal of 3 cycles) regimen of physician choice chemotherapy indicating partial, stable, complete tumor response.
10. Patients must receive Niraparib maintenance within 12 weeks after completion of their final dose of chemotherapy regimen or within 14 weeks if received radiation therapy. CT Chest/Abd/Pelvis will be performed within 28 days of starting Niraparib.
11. Lesions can be non-measurable or measurable by RECIST 1.1 criteria.
12. Adequate organ function, defined as:
1. Absolute neutrophil count ≥ 1,500/μL
2. Platelets ≥ 100,000/μL
3. Hemoglobin ≥ 9 g/dL
4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
5. Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
13. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
14. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
15. Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non childbearing potential. Non childbearing potential is defined as follows (by other than medical reasons):
1. ≥45 years of age and has not had menses for \>1 year Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 6.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
2. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
3. Able to take oral medications.

* 1. Participant must not be simultaneously enrolled in any interventional clinical trial
2. Drainage of ascites during the last 2 cycles of last chemotherapy
3. Radiotherapy was given within 2 weeks encompassing \>20% of the bone marrow or any radiation therapy within one week prior to Day 1 of protocol therapy. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
4. Persistent \>Grade 2 anemia, neutropenia, or thrombocytopenia from prior cancer therapy, that has persisted \> 4 weeks and was related to the most recent treatment.
5. Symptomatic uncontrolled brain or leptomeningeal metastases.
6. Known hypersensitivity to the components of Niraparib
7. Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery
8. Diagnosis, detection, or treatment of invasive cancer other than uterine cancer \</= 2 years prior to study enrollment (except basal or squamous cell carcinoma of the skin that has been definitively treated)
9. Patient considered a poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection.
10. Patients must not have received a transfusion within 4 weeks of the first dose of study treatment
11. Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
12. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
13. Immunocompromised patients (splenectomy patients are allowed)
14. Patients with known active hepatitis disease
15. Prior treatment with a known PARP inhibitor
16. Patients noted to have MSI-H mutational burden.

Contacts and Locations

Principal Investigator

Marina Frimer, MD

PRINCIPAL_INVESTIGATOR

Northwell Health

Study Locations (Sites)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 07103

United States

Rutgers NJ School of Medicine

Newark, New Jersey, 07103

United States

Imbert Cancer Center Northwell Health

Bay Shore, New York, 11706

United States

Greenlawn Cancer Institute, Northwell Health

Greenlawn, New York, 11740

United States

RJ Zuckerberg Cancer Hospital

New Hyde Park, New York, 11042

United States

Cancer Institute at Lenox Hill

New York, New York, 10075

United States

Collaborators and Investigators

Sponsor: Northwell Health

Marina Frimer, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-30

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2019-12-30

Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

Niraparib
uterine Cancer
papillary serous uterine cancer
endometrial cancer
serous uterine cancer
Endometrial
Endometrial Carcinoma
Recurrent Uterine Carcinoma
platinum-sensitive

Additional Relevant MeSH Terms

Endometrial Cancer
Papillary Serous Endometrial Carcinoma
Uterine Serous Carcinoma
Endometrial Carcinoma
Cancer of the Endometrium