Clinical trial · Interventional
Pilot Study of IV and IP Chemotherapy Plus Abdominal Hyperthermia for Ovarian Ca
A Pilot Study of Intravenous and Intraperitoneal Chemotherapy Plus Abdominal Hyperthermia to Treat Optimally Debulked and Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study not funded
Summary
Brief summary (as posted)
This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Chemotherapy plus Hyperthermia
- interventionNames
- Device: Hyperthermia
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer * Optimal debulking (\< 1cm residual disease) of their disease within 6 weeks of the start of the study * Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy * GOG performance status 0, 1, or 2 * Patients must have normal organ and marrow function defined as: * absolute neutrophil count \>1,500/mcL * platelets \>100,000/mcL * total bilirubin and creatinine \<1.5 X institutional upper limit of normal(ULN) * AST(SGOT)/ALT(SGPT)\<3 X institutional ULN Exclusion Criteria: * Patients with biochemical recurrences or evidence of measurable disease * Patients with suboptimal (\>1 cm) residual disease * Patients who have had chemotherapy within 4 weeks prior * Receiving any investigational agents * Known brain metastases * Epithelial ovarian carcinoma of low malignant potential (borderline carcinomas) * Uncontrolled intercurrent illness * Prior radiation therapy * History of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years
References
Publications (0)
Data not yet available