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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 have a tumor sample available for research before any treatment.
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I am scheduled for chemotherapy with carboplatin and paclitaxel.
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I am fluent in English.
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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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I am set to have surgery to remove my tumor after 3 rounds of chemotherapy.
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My kidneys are functioning well enough to clear waste.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
Paclitaxel
2011
Completed Phase 4
~5380
Durvalumab
2017
Completed Phase 2
~3870
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,251 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,144 Total Patients Enrolled
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
Fallopian Tube Cancer Research Study Groups: Treatment (durvalumab, carboplatin, paclitaxel, questionnaire)
Fallopian Tube 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any preceding research initiatives regarding Durvalumab?

"At this time, there are 1432 clinical trials that utilize Durvalumab as a form of treatment. 365 of these studies have advanced to Phase 3 status. The majority of the research centers distributing this drug are located in Shanghai; however, 74621 sites all over the world currently support its use."

Answered by AI

Are there vacancies available in this medical experiment?

"Notwithstanding clinicaltrials.gov, this particular medical trial has ceased recruiting patients; the protocol was initially posted on July 6th 2016 and last updated on June 24th 2022. However, 2052 other trials are currently enrolling participants at the moment."

Answered by AI

What is the ceiling of participants in this medical trial?

"This medical trial is no longer recruiting any new candidates. Initially posted on the 6th of July, 2016 and last edited on 24 June 2022, alternative studies with stage iv ovarian cancer ajcc v6 and v7 or Durvalumab as potential interventions are available; 620 trials for the former and 1432 for the latter are presently accepting participants."

Answered by AI

What applications of Durvalumab have been documented?

"Durvalumab is typically used for palliative therapy, but it may also be effective in the management of malignant peritoneal neoplasms and other related diseases."

Answered by AI
~2 spots leftby Dec 2024