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Alkylating agents

Durvalumab + Chemotherapy for Ovarian Cancer

Phase 1 & 2

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

No prior treatment for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube carcinoma such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy, surgery, and/or other concurrent agents or therapies

Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Must not have

Active or prior documented autoimmune disease within the past 2 years

History of allogeneic organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Summary

This trial is studying a combination of drugs as a possible treatment for ovarian, primary peritoneal, or fallopian tube cancer.

Who is the study for?

This trial is for women with advanced stage III-IV ovarian, primary peritoneal, or fallopian tube cancer who haven't had previous treatments. They should have good blood counts and organ function, not be pregnant or breastfeeding, and willing to follow the study plan. Excluded are those with certain medical conditions like uncontrolled seizures, prior immunotherapy with PD1/PD-L1 inhibitors including durvalumab, unresolved toxicities from past cancer therapies, active infections or autoimmune diseases.

What is being tested?

The N-Dur trial is testing how well the combination of durvalumab (an immunotherapy drug) works alongside chemotherapy drugs carboplatin and paclitaxel in treating patients. It's a phase I/II study aiming to see if this mix can better help the immune system attack cancer cells and prevent their growth and spread.

What are the potential side effects?

Possible side effects include typical chemotherapy-related issues like nausea, fatigue, hair loss; as well as potential effects from durvalumab such as immune reactions leading to inflammation in various organs. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't received any treatment for my advanced ovarian, peritoneal, or fallopian tube cancer.

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I am willing and able to follow the study's requirements, including treatments and visits.

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I am scheduled for chemotherapy with carboplatin and paclitaxel.

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My cancer is a high-grade type that started in the ovary, peritoneum, or fallopian tube.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have little to no nerve damage from my treatment.

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My kidneys are functioning well enough to clear waste.

Exclusion Criteria

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

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I have had an autoimmune disease in the last 2 years.

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I have received an organ from another person.

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

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I am not pregnant, breastfeeding, and I use birth control if I can have children.

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I do not have any severe illnesses that my doctors are still trying to get under control.

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I have been diagnosed with tuberculosis in the past.

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I have seizures that are not controlled by medication.

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I don't have lasting side effects from cancer treatment above mild level.

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

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I have brain metastases that need treatment.

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I am allergic to paclitaxel, carboplatin, or their ingredients.

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I have or had Crohn's disease or ulcerative colitis.

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

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I have not been treated with PD1 or PD-L1 inhibitors, including durvalumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Pharmacodynamic Changes Induced by Treatment with Durvalumab in Combination with Paclitaxel and Carboplatin in Women with Advanced Stage, Metastatic Ovarian Cancer

Pharmacodynamic Changes Induced by Treatment with Durvalumab in Combination with Paclitaxel and Carboplatin in Women with Advanced Stage, Metastatic Ovarian Cancer Using Paired T-Test

Pharmacodynamic Changes Induced by Treatment with Durvalumab in Combination with Paclitaxel and Carboplatin in Women with Advanced Stage, Metastatic Ovarian Cancer Using a 2-Sample T-Test

+1 more

Secondary study objectives

Feasibility of Treatment with Durvalumab in Combination with Paclitaxel and Carboplatin in Women with Advanced Stage, Metastatic Ovarian Cancer Determined by Methods of Thall et all

Advance Directives

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (durvalumab, carboplatin, paclitaxel, questionnaire)Experimental Treatment6 Interventions

NEOADJUVANT CHEMOTHERAPY: Before debulking surgery, patients receive durvalumab and carboplatin IV over 1 hour on day 1, and paclitaxel IV over 3 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo debulking surgery. SURGERY: After 3 courses of chemotherapy, patients undergo debulking laparoscopic surgery. ADJUVANT THERAPY: Beginning after debulking surgery, patients receive carboplatin IV over 1 hour on day 1, paclitaxel IV over 3 hours on days 1, 8, and 15, and durvalumab IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive durvalumab IV over 1 hour on day 1 and 15. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5810

Durvalumab

2017

Completed Phase 2

~3840

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,683 Total Patients Enrolled

48 Trials studying Ovarian Cancer

16,789 Patients Enrolled for Ovarian Cancer

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,982 Total Patients Enrolled

291 Trials studying Ovarian Cancer

74,941 Patients Enrolled for Ovarian Cancer

Shannon N WestinPrincipal InvestigatorM.D. Anderson Cancer Center

11 Previous Clinical Trials

1,178 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02726997 — Phase 1 & 2

Ovarian Cancer Research Study Groups: Treatment (durvalumab, carboplatin, paclitaxel, questionnaire)

Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02726997 — Phase 1 & 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02726997 — Phase 1 & 2

~2 spots leftby Dec 2025

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