Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients

• Status: Unknown status
• Trial end date: 2020-12-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrea Jewell
• Collaborator: University of Kansas Medical Center
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel

Criteria

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:

1. absolute neutrophil count ≥ 1.5 kilograms per microliter (K/UL)

2. platelets ≥ 100 K / UL

3. total bilirubin within 1.5 x normal institutional limits

4. Aspartate Aminotransferase (AST) / Serum Glutamic Oxaloacetic Transaminase (SGOT) ≤ 2.5 X institutional upper limit of normal

5. Alanine Aminotransferase (ALT) / Serum Glutamic Pyruvic Transaminase (SPGT) ≤ 2.5 X institutional upper limit of normal

6. 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 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 become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

*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)

*Note: Acceptable forms of birth control are listed below:

• 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).

Exclusion Criteria:

Participants meeting any of the exclusion criteria listed below at screening will be excluded from study participation.

• Current or anticipated use of other investigational agents.

• 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.

• ECOG 3 - 4

• 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.