Research & Innovation

Ovarian Clinical Trials

Clinical Trials

Gradalis CL-PTL-135

Physician & Study Coordinator

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Synopsis

Blood and Tissue Procurement Protocol for Product Development and Research.

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Eligibility Criteria
  • Patients must agree to collection of blood and/or tumor tissue/fluid that is obtained during a standard of care procedure or visit (as of 5/11/23 - no blood collection is necessary unless specifically requested by sponsor)
  • For Ovarian cancer - fresh tissue collection of frontline, newly diagnosed, treatment naive, Stage IIIb or IV or first recurrenct, platinum-sensitive tumors (tissue collection must occur prior to initiation of any systemic therapy for recurrence)
  • For Ovarian cancer - fluid collection from first tap of ascited or pleural fluid of first recurrence, platinum-sensitive tumors (can be collected prior to or after systemic therapy for recurrence is initiated)

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MD Anderson MDACC_2020-0165 (LANCE)

Physician & Study Coordinator

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Synopsis

The goal of this clinical research study is to compare the outcomes of minimally invasive surgery to laparotomy, the current standard of care in women with epithelial ovarian cancer who receive chemotherapy before and after surgery. Researchers want to learn if one surgery can prevent the disease from returning for longer, and/or improve quality of life after surgery.

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Eligibility Criteria

Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows: 

  • Patients must be 18 years of age or older and have an ECOG performance score of 0-2
  • Patients must have stage IIIC or IV high-grade, invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian-tube carcinoma or pathology consistent with high-grade mullerian carcinoma
  • Patient must be considered by a treating physician to be a surgical candidate after completing 3 to 4 cycles of platinum-based chemotherapy, or an investigational neoadjuvant regimen given according to protocol, with complete radiologic resolution of any disease outside the abdominal cavity
  • CA-125 normalization or a value ≤ 500 and scheduled to undergo a diagnostic laparoscopy prior to debulking surgery (Patients with a normal CA-125 at initiation of chemotherapy, the CA-125 cannot exceed 35 U/mL at the completion of NACT prior to interval debulking surgery)
  • Evidence of tumor not amenable to minimally invasive resection on pre-operative imaging is not allowed

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NRG-GY036

A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA 1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum Based Chemotherapy (NCT 06580314).

Physician & Study Coordinator

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Synopsis

The purpose of this Phase III trial is to help determine if one year of Olaparib with or without bevacizumab is as good as or worse than two years of Olaparib with or without bevacizumab in preventing ovarian cancer from growing or returning after receiving standard platinum based therapies.

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Eligibility Criteria

Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Patients must have FIGO Stage III or IV high grade serous, endometrioid or other epithelial ovarian cancer with BRCA 1/2 deleterious mutation OR BRCA 1/2 wildtype AND known HRD deficient tumor determined by a CLIA-certified laboratory
  • Patients must have undergone cytoreductive surgery
  • Patients must have completed first line platinum-based therapy within 3-12 weeks prior to study registration and have no clinical evidence of disease progression following completion of this chemotherapy course
  • Patients must be ≥ 18 years old and have an ECOG Performance Status of ≤ 2
  • Patients must be able to swallow oral pills
  • No history of prior PARP inhibitor therapy

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