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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

- Decline in serum cancer antigen (CA) 125 level

Serum albumin >= 2.5

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upfrom 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

Study Summary

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

Eligible Conditions

Fallopian Tube Cancer
Uterine Corpus Cancer
Ovarian Cancer
Peritoneal Cancer
Uterine Cancer
Peritoneal Carcinoma

Eligibility Criteria

Inclusion Criteria

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

Select...

You don't currently have an infection that needs treatment with antibiotics.

Select...

The study is measuring changes in the amount of fluid in your abdomen.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

~1940

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9860

Pegylated Liposomal Doxorubicin Hydrochloride

2001

Completed Phase 3

~4520

Carboplatin

2014

Completed Phase 3

~6670

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Paclitaxel

2011

Completed Phase 4

~5380

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

550 Previous Clinical Trials

2,252,526 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,486 Previous Clinical Trials

41,264,801 Total Patients Enrolled

Thanh DellingerPrincipal InvestigatorCity of Hope Medical Center

1 Previous Clinical Trials

29 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01970722 — Phase 1

Fallopian Tube Cancer Research Study Groups: Treatment (surgery, HIPEC cisplatin)

Fallopian Tube Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01970722 — Phase 1

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01970722 — Phase 1

Frequently Asked Questions

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

Is Cisplatin being evaluated in any other clinical experiments?

"Cisplatin was initially investigated in Spectrum Health Hospital - Butterworth Campus during 1997. As of now, there are 3903 finished studies and 1961 on-going clinical trials, the majority of which are based out of Corona, California."

Answered by AI

Does this trial use innovative techniques?

"At this time, there are 1961 active Cisplatin trials occurring in 89 countries and 4076 cities. The first such study was sponsored by Alfacell back in 1997; it had 300 participants and concluded its Phase 3 medicinal tests with success. Subsequent to that initial trial, 3903 other research projects have been performed."

Answered by AI

How many individuals are taking part in this clinical experiment?

"As the trial was last modified on June 14th 2022, this research is no longer accepting applicants. However, there are currently 3687 studies for stage iiic uterine corpus cancer ajcc v7 and 1961 trials for Cisplatin that require volunteers."

Answered by AI

At which hospitals is this clinical investigation being conducted?

"Currently, the trial is being conducted at 4 separate sites: Corona, Upland, Duarte and four other locales. To reduce travel time commitments it is advisable to choose the most proximal location if participating in this study."

Answered by AI

What ailment is Cisplatin most frequently deployed to combat?

"Cisplatin is primarily used to treat typhus, however it can also aid in the management of Kaposi's Sarcoma AIDS related infections, Helicobacter Pylori infection and Endometritis."

Answered by AI

Has the FDA sanctioned Cisplatin for therapeutic use?

"The safety of cisplatin was assigned a score of 1 on the scale, reflecting its status as being in Phase 1 and having limited data to demonstrate efficacy or safety."

Answered by AI

Are there any opportunities available to participate in this research?

"According to the available public data hosted on clinicaltrials.gov, this medical trial is not recruiting participants at this current moment in time. The first post was made on May 19th 2014 and last updated June 14 2022; yet there are still 5648 other studies actively searching for individuals who wish to contribute to furthering research efforts."

Answered by AI

Recent research and studies

JCO Precision OncologyJournal

Hyperthermic Intraperitoneal Chemotherapy–induced Molecular Changes in Humans Validate Preclinical Data in Ovarian Cancer

Dellinger, Thanh H., Ernest S. Han, Mustafa Raoof, Byrne Lee, Xiwei Wu, Hyejin Cho, Ting-Fang He, et al.. 2022. “Hyperthermic Intraperitoneal Chemotherapy–induced Molecular Changes in Humans Validate Preclinical Data in Ovarian Cancer”. JCO Precision Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/po.21.00239.

JCO Precision OncologyJournal

Hyperthermic Intraperitoneal Chemotherapy–induced Molecular Changes in Humans Validate Preclinical Data in Ovarian Cancer

clinicaltrials.govStudy

Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer

2014. "Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01970722.

All > Peritoneal Cancer > Recurrent Ovarian Cancer