Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT01970722|
Recruitment Status : Recruiting
First Posted : October 28, 2013
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Uterine Corpus Cancer Recurrent Fallopian Tube Cancer Recurrent Ovarian Cancer Recurrent Primary Peritoneal Cancer Stage IIIA Uterine Corpus Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Cancer Stage IIIA Primary Peritoneal Cavity Cancer Stage IIIB Uterine Corpus Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Cancer Stage IIIB Primary Peritoneal Cavity Cancer Stage IIIC Uterine Corpus Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Cancer Stage IIIC Primary Peritoneal Cavity Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Primary Peritoneal Cavity Cancer Stage IVA Uterine Corpus Cancer Stage IVB Uterine Corpus Cancer||Procedure: therapeutic conventional surgery Drug: cisplatin Drug: carboplatin Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment Other: laboratory biomarker analysis||Phase 1|
I. To determine whether cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative normothermic intraperitoneal (IP) chemotherapy is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.
I. To determine quality of life (QoL) and compare the outcomes to a historical control of IP chemotherapy (no HIPEC) for women with ovarian cancer.
II. To determine whether cytoreductive surgery with HIPEC alone is feasible and safe to administer, as measured by toxicities occurring during treatment or follow-up.
III. To estimate progression-free survival (PFS).
IV. To collect biospecimens and perform correlative translational studies focused on understanding the mechanisms of action of HIPEC on ovarian cancer and micro ribonucleic acid (RNA) profiling of ovarian cancer and ex vivo evaluation of oncolytic virus replication.
OUTLINE: Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (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 intravenously (IV) at the discretion of the medical and gynecologic oncologists.
After completion of study treatment, patients are followed up at 3-6, 6-9, 9-12, and 12-15 months; every 3 months for 1 year; and then every 4 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Optional Postoperative Normothermic Intraperitoneal (IP) Chemotherapy to Treat Primary or Recurrent Carcinoma of Ovarian, Fallopian Tube, Uterine, or Peritoneal Origin|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Treatment (surgery, HIPEC cisplatin)
Patients undergo surgery and receive hyperthermic cisplatin intraperitoneally (IP) over 60 minutes.
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.
Procedure: therapeutic conventional surgery
Given IP or IV
Given IP or IV
Drug: pegylated liposomal doxorubicin hydrochloride
Given IP or IV
Drug: gemcitabine hydrochloride
Given IP or IV
Procedure: quality-of-life assessment
Other Name: quality of life assessment
Other: laboratory biomarker analysis
- Treatment-related toxicities according to NCI CTCAE guidelines [ Time Frame: Up to 3 months post-surgery ]Toxicity for both primary and recurrent groups will be summarized using frequency tables.
- QoL assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) QoL questionnaire [ Time Frame: Up to 15 months post-surgery ]The FACT-O has four subscales: physical, social/family, emotional, and functional well-being. Answers are on a scale of 0 'not at all' to 4 'very much'. To estimate effect sizes over time, generalized linear models will be used to estimate the correlations between potential prognostic factors. Generalized estimating equations (GEEs) have utility in modeling longitudinal effects across time in prospective cohorts, and the models will include time-dependent covariate structures for continuous outcomes. QoL will be compared to a historical control of IP chemotherapy for women with ovarian cancer.
- PFS [ Time Frame: Time-of-study entry to time-of-detection of new lesions on CT imaging that is triggered by cancer antigen 125 (CA125) progression as defined by Gynecologic Cancer Intergroup Criteria (GCIG) or clinical symptoms or deterioration, assessed up to 3 years ]PFS will be estimated in both groups. The survival curve will be estimated using Kaplan-Meier method and graphically displayed along with the corresponding 95% confidence curves. The Cox proportional hazards model will be used to derive an estimate of the hazard ratio and its corresponding 95% confidence limits.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970722
|Contact: Kathleen Kelly||626 256-4673 ext email@example.com|
|United States, California|
|City of Hope Corona||Recruiting|
|Corona, California, United States, 92879|
|Contact: Cheryl Corpus 626-256-4673 ext 81529|
|Contact: Misagh Karimi, MD 626-256-4673|
|Principal Investigator: Misagh Karimi, MD|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Thanh Dellinger 800-826-4673|
|Principal Investigator: Thanh Dellinger|
|City of Hope Rancho Cucamonga||Recruiting|
|Rancho Cucamonga, California, United States, 91730|
|Contact: Valerie Estala 626-256-4673 ext 81699|
|Principal Investigator: Behnam Ebrahimi, MD|
|Principal Investigator:||Thanh Dellinger||City of Hope Medical Center|