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Alkylating agents

Surgery + Chemotherapy for Ovarian Cancer

Phase 1

Waitlist Available

Led By Thanh Dellinger

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by ca125 progression as defined by gynecologic cancer intergroup criteria (gcig) or clinical symptoms or deterioration, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing surgery with or without heated and unheated chemotherapy for ovarian, fallopian tube, uterine, or peritoneal cancer.

Who is the study for?

This trial is for patients with stage III or IV ovarian, fallopian tube, uterine, or peritoneal cancer that's confined to the abdominal cavity. It includes those who've had neoadjuvant chemotherapy and surgery. Participants must be in good physical condition (ECOG <=1 or KPS >=70%), respond well to platinum-based treatments, have no active infections requiring antibiotics, and not be pregnant. They should also have adequate organ function and blood counts.

What is being tested?

The study tests how effective heated chemotherapy during surgery is compared to adding non-heated chemo after surgery for certain cancers. The goal is to see if heated chemo can better prevent cancer from returning by killing more tumor cells when applied directly into the abdomen during surgical removal of the cancer.

What are the potential side effects?

Potential side effects include reactions related to chemotherapy such as nausea, fatigue, hair loss (alopecia), nerve damage (neuropathy), blood cell count changes leading to increased infection risk or bleeding problems, liver and kidney function alterations, and complications from surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by ca125 progression as defined by gynecologic cancer intergroup criteria (gcig) or clinical symptoms or deterioration, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by ca125 progression as defined by gynecologic cancer intergroup criteria (gcig) or clinical symptoms or deterioration, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time-of-study entry to time-of-detection of new lesions on computed tomography imaging that is triggered by ca125 progression as defined by gynecologic cancer intergroup criteria (gcig) or clinical symptoms or deterioration, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of treatment-related toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines

Secondary study objectives

Progression-free survival (PFS)

Quality of life (QoL) assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QoL questionnaire

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 (surgery, HIPEC cisplatin)Experimental Treatment8 Interventions

Patients undergo surgery and receive hyperthermic cisplatin IP over 60 minutes. Beginning at least 3 weeks after surgery, patients may receive carboplatin, paclitaxel, pegylated liposomal doxorubicin hydrochloride, or gemcitabine hydrochloride IP or IV at the discretion of the medical and gynecologic oncologists.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9930