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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
Study 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.Check my eligibility
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.See study design
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
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
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
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Cisplatin
2013
Completed Phase 3
~1940
Pegylated Liposomal Doxorubicin Hydrochloride
2001
Completed Phase 3
~4520
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,113 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,420 Total Patients Enrolled
Thanh DellingerPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
29 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer in areas outside of the abdomen, such as in the chest with fluid buildup around the lungs. If you had this before but it's no longer there after treatment, you may still be able to join the study.Your surgery did not remove all of the unhealthy tissue.If a quick test during surgery shows you have certain types of cancer in your liver, gallbladder, pancreas, adrenal gland, or urinary tract, you cannot participate.You have advanced or recurrent ovarian, fallopian tube, peritoneal, or uterine cancer that has spread within the abdomen.You may need to have a major surgery to remove cancer, and your doctor thinks it's a good idea.You should be able to perform daily activities without difficulty or needing help.You have previously been treated with platinum-based chemotherapy and it either worked well or didn't work well for you.You have other active cancers, except for non-melanoma skin cancer and breast cancer that has been treated and has no evidence of disease for at least 1 year.You have cancer that has spread from a non-gynecologic or breast source.You have heart or lung conditions that make it unsafe to have extensive surgery.If you have ovarian, tubal, or peritoneal cancer and have received chemotherapy before surgery, there should be evidence that the chemotherapy has worked. Your blood tests and other assessments need to meet certain criteria, and you should be in a stable condition to undergo surgery.Your cancer has not responded to at least three cycles of chemotherapy, or your condition has worsened based on specific measurements or symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (surgery, HIPEC cisplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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
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