← Back to Search

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

Must not have

Histology showing mucinous or low grade epithelial carcinoma

Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up u to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am fully active or can carry out light work.

Select...

My cancer is a high-grade type that started in my ovaries, peritoneum, or fallopian tubes and is not mucinous.

Select...

My kidney function, measured by creatinine clearance, is adequate.

Select...

I have little to no nerve damage from previous treatments.

Select...

My cancer has a BRCA mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer is either mucinous or a low-grade epithelial type.

Select...

I have received treatment for ovarian, fallopian tube, or peritoneal cancer.

Select...

I am not able to participate in the study's surveys because I do not speak English.

Select...

I have had cancer spread to the lining of my brain and spinal cord.

Select...

I have brain metastases that need treatment.

Select...

I don't have lasting side effects from cancer treatment, except for hair loss.

Select...

I have had a bone marrow or cord blood transplant in the past.

Select...

I am not taking strong or moderate CYP3A inhibitor medications.

Select...

I have never been treated with a PARP inhibitor like olaparib.

Select...

I had major surgery more than 2 weeks ago and have recovered from it.

Select...

I do not have any severe illnesses or conditions that are not under control.

Select...

I cannot swallow pills or have a stomach condition that affects medication absorption.

Select...

I am not taking any strong or moderate drugs that affect liver enzymes.

Select...

I have been diagnosed with MDS/AML or show signs of it.

Select...

I have seizures that are not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ u to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~u to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and u to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of olaparib

Secondary study objectives

Complete pathologic response

Incidence of adverse events

Progression-free survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~2190