Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    20
  • sponsor
    Andrea Jewell
Updated on 25 March 2022
mucinous adenocarcinoma
paclitaxel
cancer
carcinoma
neutrophil count
carboplatin
cancer chemotherapy
adenocarcinoma
ovarian cancer
fallopian tube
undifferentiated carcinoma
endometrioid adenocarcinoma
clear cell adenocarcinoma
serous adenocarcinoma
endometrioid carcinoma
carboplatin/paclitaxel
primary peritoneal carcinoma
peritoneal carcinoma
tumor debulking
cytoreductive surgery
intraperitoneal chemotherapy
cytoreduction
serous cystadenocarcinoma
cancer of the ovary

Summary

This study will evaluate the use of Heated Intraperitoneal Chemotherapy (HIPEC) for primary treatment of ovarian cancer at the time of surgical debulking, to assess if intravenous (IV) chemotherapy can be started within 42 days of HIPEC and cytoreduction. All patients will receive cytoreductive surgery followed by a one-time closed HIPEC with cisplatin at 41-43 degrees Celsius for 90 minutes in the operating room. This is followed by 6 cycles of intravenous carboplatin and paclitaxel on an outpatient basis.

Description

Heated Intraperitoneal chemotherapy (HIPEC) has several potential benefits. High-dose chemotherapy can be used due to the plasma-peritoneal barrier resulting in little absorption into the blood stream. Additionally, there is higher peritoneal penetration in comparison to IV regimen, and does not have the limitation of traditional IP regimen of post-operative adhesions. Hyperthermia itself has cytotoxic effects and can increase the depth of tumor penetration by the chemotherapeutic agent up to 3 millimeters; moreover, hyperthermia can potentiate its antineoplastic effects.

In recent times, morbidity and mortality associated with HIPEC has drastically improved. One large retrospective review of 694 patients, treated between 2005 and 2011, utilizing the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQUIP) database, demonstrated a complication rate of 33% and 30-day mortality of 2.3%, both rates consistent with outcomes for other major complex abdominal operations.

Recently, a Phase I dose escalation study to evaluate maximum tolerated dose (MTD) of HIPEC administration of cisplatin in recurrent epithelial ovarian cancer (EOC) patients was published. The MTD of cisplatin was 100 milligrams per meter squared (mg/m2) with no mortality or safety concerns. While the trial had only 12 patients, all were able to receive post-operative IV chemotherapy, with all patients completing at least five cycles.

In protocol Gynecologic Oncology Group (GOG)-0172, intraperitoneal cisplatin and paclitaxel, plus intravenous paclitaxel, demonstrated the longest median survival reported in optimally debulked stage III ovarian cancer. Currently, the GOG is studying variations of the intraperitoneal (IP) regimen to preserve the survival advantage, but make it tolerable for patients to receive 6 cycles without discontinuing therapy due to distress and toxicity. The importance of developing an acceptable GOG-0172 alternative is emphasized by the recent National Cancer Institute (NCI) Clinical Announcement recognizing the superiority of intraperitoneal chemotherapy in the optimal disease setting.

Details
Condition Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer
Treatment carboplatin, Paclitaxel, HIPEC
Clinical Study IdentifierNCT03321188
SponsorAndrea Jewell
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent
Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, Stage 3(III)B - 3(III)C with optimal (≤ 1 centimeter) residual disease
Patients with the following histologic epithelial cell types are eligible
Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified
No previous HIPEC
Patient has a planned cytoreduction surgery - Note: registration occurs during surgery and not before; if, during surgery, the Principal Investigator/Sub-Investigator discerns that all disease cannot be removed surgically, the participant will be considered a "screen failure", HIPEC will not be performed, and the participant will be removed from the study
Age ≥ 18 years
Performance Status Eastern Cooperative Group (ECOG) 0- 2
Adequate organ and marrow function as defined below
absolute neutrophil count ≥ 1.5 kilograms per microliter (K/UL)
platelets ≥ 100 K / UL
total bilirubin within 1.5 x normal institutional limits
Aspartate Aminotransferase (AST) / Serum Glutamic Oxaloacetic Transaminase (SGOT) ≤ 2.5 X institutional upper limit of normal
Alanine Aminotransferase (ALT) / Serum Glutamic Pyruvic Transaminase (SPGT) ≤ 2.5 X institutional upper limit of normal
creatinine within 1.5 x normal institutional limits
Note: If a potential participant has non-clinically significant variances related to the organ and marrow parameters listed above, PI review and approval is required before enrollment
Women of child-bearing potential and their male partners also of child-bearing
potential must agree to use adequate contraception (hormonal or barrier method
A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria
Has not undergone a hysterectomy or bilateral oophorectomy; OR Has not been naturally postmenopausal for at least 12 consecutive months (has had menses at any time in the preceding 12 consecutive months)
of birth control; abstinence) prior to study entry, for the duration of study
participation, and for 90 days following completion of therapy. Should a woman
Note: Acceptable forms of birth control are listed below
become pregnant or suspect she is pregnant while participating in this study
One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) Plus Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
she should inform her treating physician immediately

Exclusion Criteria

Current or anticipated use of other investigational agents
Participants meeting any of the exclusion criteria listed below at screening will be
excluded from study participation
ECOG 3 - 4
Patient has received chemotherapy or radiotherapy within 4 weeks prior to entering the
study or has not recovered sufficiently (PI will judge patient recovery status) from
adverse events due to agents administered more than 4 weeks earlier
Patient has history of or currently has non-peritoneal surface macroscopic metastatic
disease in addition to peritoneal surface malignancy such as macroscopic pulmonary
disease or other macroscopic disease outside of the peritoneal cavity
Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly
tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer
treated with surgery only (such as those with stage Ia or Ib low Grade lesions) are
not eligible. Patients with a prior diagnosis of a borderline tumor that was
surgically resected and who subsequently develop an unrelated, new invasive epithelial
ovarian or peritoneal primary cancer are eligible, provided that they have not
received prior chemotherapy for any ovarian tumor
Patients with synchronous primary endometrial cancer, or a past history of primary
endometrial cancer, are excluded, unless all of the following conditions are met
Stage not greater than I-B; no more than superficial myometrial invasion, without
vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary
serous, clear cell or other International Federation of Gynecology and Obstetrics
(FIGO) Grade 3 lesions
Patients with history or current diagnosis of inflammatory bowel disease are not
eligible
History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Cisplatin, carboplatin and paclitaxel or other agents used in study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia
Current psychiatric illness/social situations that would limit compliance with study
requirements
Pregnant or nursing. There is a potential for congenital abnormalities and for this
regimen to harm nursing infants
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