Clinical trial · Interventional
Intraperitoneal Hyperthermic Perfusion With Oxaliplatin in Treating Patients With Stage IV Peritoneal Cancer Due to Appendix Cancer or Colorectal Cancer
A Phase I Evaluation of Intraperitoneal Hyperthermic Chemoperfusion With Oxaliplatin for Peritoneal Surface Disemmination of Appendiceal and Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Adding chemotherapy to hyperthermia and infusing it directly into the abdomen may kill more tumor cells. Giving this treatment after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal hyperthermic perfusion with oxaliplatin in treating patients with stage IV peritoneal cancer due to appendix cancer or colorectal cancer.
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 |
|---|---|---|---|
| Carcinoma of the Appendix | Appendix Carcinoma | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hyperthermic Chemoperfusion with Oxaliplatin 200 mg/m2
- description
- Intraperitoneal Hyperthermic Chemoperfusion with Oxaliplatin 200 mg/m2
- interventionNames
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- Hyperthermic Chemoperfusion with Oxaliplatin 250 mg/m2
- description
- Intraperitoneal Hyperthermic Chemoperfusion with Oxaliplatin 250 mg/m2
- interventionNames
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 18 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colorectal or appendiceal cancer * Stage IV disease * Peritoneal surface dissemination of disease (peritoneal carcinomatosis) * Measurable disease according to RECIST criteria * No active CNS metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min * Bilirubin ≤ 1.5 mg/dL * Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN * No active infection or fever ≥ 101.3°F within the past 3 days * No other malignancy within the past 5 years except curatively treated basal cell skin cancer, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate-specific antigen of \< 1.0 mg/dL on 2 successive evaluations, ≥ 3 months apart, with the last evaluation within the past 4 weeks * No peripheral neuropathy ≥ grade 2 * No other medical condition, mental illness, or substance abuse that, in the opinion of the principal investigator, would preclude study compliance * No known hypersensitivity to any component of oxaliplatin * No known HIV positivity * No hepatitis B or C positivity (active, previously treated, or both) * Not pregnant or nursing * Negative pregnancy test * Fertile patients and their partners must use effective contraception during and for 90 days after completion of study treatment PRIOR CONCURRENT THERAPY: * Recovered from prior surgery, radiotherapy, and other anticancer therapies * More than 30 days since prior and no other concurrent investigational therapy * No prior radiotherapy to \> 25% of bone marrow * No prior allogeneic stem cell transplantation * No concurrent antiretroviral therapy
References
Publications (1)
- RESULTStewart JH 4th, Shen P, Russell G, Fenstermaker J, McWilliams L, Coldrun FM, Levine KE, Jones BT, Levine EA. A phase I trial of oxaliplatin for intraperitoneal hyperthermic chemoperfusion for the treatment of peritoneal surface dissemination from colorectal and appendiceal cancers. Ann Surg Oncol. 2008 Aug;15(8):2137-45. doi: 10.1245/s10434-008-9967-1. Epub 2008 May 21. PMID 18493824