Clinical trial · Interventional
WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Request
Summary
Brief summary (as posted)
This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor \> or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6 cycles.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Hyperthermic intraperitoneal chemotherapy with Carboplatin | Drug | — | UNRESOLVED |
| Isotonic saline (perfusate) | Other | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIPC Treatment
- interventionNames
- Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin
- Other: Isotonic saline (perfusate)
- Procedure: Surgery
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- Clinical Response
- timeFrame
- After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)
- description
- We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.
- measure
- Feasibility of HIPC in Recurrent Disease Setting
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients should have a histological diagnosis of primary ovarian, fallopian tube, or primary peritoneal carcinoma and have undergone chemotherapy according. * Initial attempted cytoreductive surgery must have been performed by gynecologic oncologist with strict adherence to GOG surgical manual. * End result of first surgery must have been optimal cytoreduction as defined as no residual tumor ≥ 1cm. * Patients should have clinical evidence of first recurrence. Two fold elevations in CA125 or measurable tumor on CT scan constitute adequate evidence of recurrent disease. * Patients with the following primary tumor epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma (non-specific) NOS, mixed epithelial carcinoma. * Patients must have platin sensitive disease, defined as a recurrence occurring greater than 6 months from cessation of original treatment. * Patients must have a performance status of 0, 1, 2. * Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) ≥1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl. * Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl. * Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels. * Patients who have signed an Institutional Review Board (IRB) approved informed consent. * Female patients 16-90 years of age. * Patients must be deemed medically able to undergo a secondary surgical procedure. Patient eligibility for systemic chemotherapy following HIPC: * Patients must have successfully completed HIPC within 6 weeks of first prescribed intravenous carboplatin and taxane cycle. * Patients must have a performance status of 0, 1, or 2. * Patients must have adequate bone marrow function as defined as an ANC ≥ 1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl. * Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl. * Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels. * Patients who have signed an IRB approved informed consent. Exclusion Criteria: * Patients with known recurrent disease outside the abdominal cavity. * Patients with low malignant tumor at primary diagnosis as determined by pathologic review. * Patients with platin resistant disease as define as recurrence or progressive disease prior to 6 months from completion of primary therapy. * Patients with any evidence of another malignancy within the last 5 years with the exception of non-melanoma skin cancer. * Patients with evidence of concurrent septicemia, severe infection, renal failure, or acute hepatitis. * Patients with history of grade 3 or greater gastrointestinal bleeding. * Patients with a GOG performance score of 3 or 4. * Patients deemed medically unable to tolerate the HIPC procedure by care giving physician. * Patients with known allergy to platinum chemotherapy agents. * Patients with equal to or greater than grade 2 neuropathy.
References
Publications (0)
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