Overview

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

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Comprehensive Cancer Center of Wake Forest University
Wake Forest University Health Sciences
Collaborator:
National Cancer Institute (NCI)
Treatments:
Oxaliplatin
Criteria
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