Intraperitoneal Hyperthermic Perfusion With Oxaliplatin in Treating Patients With Stage IV Peritoneal Cancer Due to Appendix Cancer or Colorectal Cancer

NCT00458809 | Completed Phase 1 DMC FDA Drug

• 5 other identifiers: CDR0000540283P30CA012197CCCWFU-59106CCCWFU-IRB00000847CCCWFU-59106 IPHC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Carcinoma of the Appendix; Colorectal Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; carcinoma of the appendix; recurrent rectal cancer; stage IV rectal cancer; primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  Maximum tolerated dose will be determined by the absence of dose limiting toxicites (serious adverse events related to Oxaplatin dosing within 18 days of administration)

  18 days

Secondary Outcomes (2)

• Pharmacokinetics

  day of surgery (day one)

• Change in the phenotypic expression of proteins involved in the apoptotic and heat-stress inducible pathways

  Day of surgery (day one)

Study Arms (2)

Hyperthermic Chemoperfusion with Oxaliplatin 200 mg/m2

EXPERIMENTAL

Intraperitoneal Hyperthermic Chemoperfusion with Oxaliplatin 200 mg/m2

Drug: oxaliplatin

Hyperthermic Chemoperfusion with Oxaliplatin 250 mg/m2

EXPERIMENTAL

Intraperitoneal Hyperthermic Chemoperfusion with Oxaliplatin 250 mg/m2

Drug: oxaliplatin

Interventions

oxaliplatin DRUG

Intraperitoneal Hyperthermic Chemoperfusion with Oxaliplatin

Hyperthermic Chemoperfusion with Oxaliplatin 200 mg/m2; Hyperthermic Chemoperfusion with Oxaliplatin 250 mg/m2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Related Publications (1)

• Stewart 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 RESULT

MeSH Terms

Conditions

Appendiceal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases; Colonic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• John H. Stewart, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

US (1)