Clinical trial NCT04415944: Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy
Official title: A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Epithelial Cancer Stage I
Ovarian Epithelial Cancer Stage II
Ovarian Epithelial Cancer Stage III
Stage I Fallopian Tube Cancer
Stage II Fallopian Tube Cancer
Stage III Fallopian Tube Cancer
Peritoneal Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-04
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

Detailed description: Primary Objective: Determine the feasibility of second look laparoscopy and hyperthermic intraperitoneal chemotherapy with carboplatin.

Secondary Objective(s)

* To compare the quality if life in patients with ovarian cancer after undergoing second look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy using carboplatin (CBDCA) versus quality of life in patients treated with cytoreduction surgery and systemic chemotherapy alone.
* To describe toxicities in patients with ovarian cancer treated with second look laparoscopy and simultaneous hyperthermic intraperitoneal chemotherapy.

OUTLINE:

Patients undergo second look laparoscopy. Patients with visible signs of cancer in abdomen also receive HIPEC with carboplatin via intraperitoneal injection (IP) over 90 minutes in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 6 months.

Eligibility criteria: Inclusion Criteria:

* Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian tube or peritoneum or Stage IVA disease in which is there complete resolution of disease (pleural effusion) with chemotherapy
* Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-based systemic chemotherapy prior to the second look surgery. Systemic platinum based chemotherapy must be completed less than 18 weeks prior to second look surgery.
* Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy
* The intraoperative peritoneal adhesion index should be \< 10.
* Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy.
* Age ≥ 18 years.
* ECOG performance status ≤ 2.
* Patients must have adequate organ and marrow function as defined below (within 30 days of registration): absolute neutrophil count \>1,500/mcL; platelets \>100,000/mcL; total bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X; institutional upper limit of normal; alkaline phosphatase 3X institutional upper limit of normal
* Adequate contraception and negative pregnancy test if pregnancy possible.
* Ability to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria:

* Patients greater than 18 weeks from their last course of systemic platinum based chemotherapy
* Patients who have received additional chemotherapy for the ovarian cancer after primary therapy as outlined above.
* Patients may not have received prior abdominal or pelvic radiation.
* Extensive intra-abdominal adhesive disease noted at the time of initial cytoreductive surgery with PAI of \>10 as defined above
* Intra-abdominal infection associated with initial cytoreductive surgery requiring extended hospitalization or related to systemic chemotherapy requiring hospitalization for therapy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnancy

Men are excluded from participation due to the site-specific nature of the disease being studied.

Primary outcomes:
measure: Number of Patients To Succesfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy
timeFrame: Up to 3 months post treatment
Secondary outcomes:
measure: Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire
timeFrame: Up to 6 months post-treatment
measure: Number of Reported Toxicities
timeFrame: Up to 3 months post treatment
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Laurel Berry, MD
role: PRINCIPAL_INVESTIGATOR
References: