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Alkylating agents
Olaparib for Ovarian and Peritoneal Cancer
Phase < 1
Waitlist Available
Led By Shannon N Westin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up u to 1 year
Awards & highlights
Study Summary
This trial is testing olaparib to see if it can stop the growth of cancer cells in patients with BRCA-mutant ovarian, primary peritoneal, or fallopian cancer.
Who is the study for?
This trial is for patients with newly diagnosed BRCA-mutant ovarian, primary peritoneal, or fallopian cancer who haven't had surgery yet. Eligible participants must have good blood counts and organ function, be able to perform daily activities with ease or only slight limitation (ECOG 0-1), and not be pregnant. They shouldn't have received prior treatment for these cancers or any PARP inhibitors like olaparib.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Olaparib before surgery in stopping tumor growth in patients with specific types of cancer linked to BRCA mutations. It's an early phase I study which means it's one of the first times this approach is being tried out to see how well it works and how safe it is.See study design
What are the potential side effects?
Olaparib may cause side effects such as nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, and less commonly lung inflammation or kidney issues. The severity can vary from mild symptoms that don't need treatment to more serious ones that do.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer is a high-grade type that started in my ovaries, peritoneum, or fallopian tubes and is not mucinous.
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My kidney function, measured by creatinine clearance, is adequate.
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I have little to no nerve damage from previous treatments.
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My cancer has a BRCA mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ u to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~u to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of olaparib
Secondary outcome measures
Complete pathologic response
Incidence of adverse events
Progression-free survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib)Experimental Treatment3 Interventions
Patients receive olaparib PO BID on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After treatment, patients either undergo surgery then receive standard chemotherapy for up to 4 cycles or receive standard chemotherapy within 14 days for up to 4 cycles then undergo surgery in the absence of disease progression or unacceptable toxicity at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Olaparib
2007
Completed Phase 4
~2210
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,299 Total Patients Enrolled
23 Trials studying Fallopian Tube Carcinoma
6,798 Patients Enrolled for Fallopian Tube Carcinoma
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,220 Total Patients Enrolled
4 Trials studying Fallopian Tube Carcinoma
600 Patients Enrolled for Fallopian Tube Carcinoma
Shannon N WestinPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
1,181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzyme levels must be within a certain range, unless you have cancer that has spread to the liver.Your bilirubin level in the blood is not more than 1.5 times the normal limit.My cancer is either mucinous or a low-grade epithelial type.I have received treatment for ovarian, fallopian tube, or peritoneal cancer.I am not able to participate in the study's surveys because I do not speak English.You have had a bad reaction to olaparib or any of the ingredients in it.I am set to start chemotherapy before surgery to shrink my tumor after 3 cycles.Your resting ECG shows uncontrolled heart problems that can possibly be fixed.I have had cancer spread to the lining of my brain and spinal cord.I have not received a whole blood transfusion in the last 4 months.I have brain metastases that need treatment.I don't have lasting side effects from cancer treatment, except for hair loss.Your white blood cell count is higher than 1500 per mm3.You have a disease that can be measured or evaluated according to specific guidelines.I have had a bone marrow or cord blood transplant in the past.I am fully active or can carry out light work.My cancer is a high-grade type that started in my ovaries, peritoneum, or fallopian tubes and is not mucinous.I am not taking strong or moderate CYP3A inhibitor medications.I have had cancer before, but it was either treated over 5 years ago, was a non-melanoma skin cancer, or was a localized cancer that did not spread.My kidney function, measured by creatinine clearance, is adequate.I have never been treated with a PARP inhibitor like olaparib.I had major surgery more than 2 weeks ago and have recovered from it.I do not have any severe illnesses or conditions that are not under control.Your hemoglobin level should be 10.0 grams per deciliter or higher, and you shouldn't have had a blood transfusion in the past 28 days.I cannot swallow pills or have a stomach condition that affects medication absorption.I am not taking any strong or moderate drugs that affect liver enzymes.You are expected to live for at least 16 weeks.I have been diagnosed with MDS/AML or show signs of it.I have little to no nerve damage from previous treatments.I have seizures that are not controlled by medication.Your platelet count is at least 100,000 per mm3.My cancer has a BRCA mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (olaparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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