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Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis


Phase 1
N/A
N/A
Not Enrolling
Both
Peritoneal Neoplasms, Stomach Neoplasms

Thank you

Trial Information

Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis


Patients with gastric adenocarcinoma are most frequently diagnosed at an advanced stage.
The disease has a marked propensity for loco-regional spread and will be the sole or major
site of disease in up to 80% of patients. Various attempts at controlling loco-regional
disease have not been successful. The selective lethal effect of supranormal temperatures
on neoplastic cells and the additive or synergistic effect of combining chemotherapy has
been well established in laboratory models and has provided the rationale for numerous
clinical trials using hyperthermic isolated limb perfusion for advanced extremity melanoma
or sarcoma. This Phase I study will evaluate the safety of escalating temperatures of
continuous hyperthermic peritoneal perfusion (CHPP) with escalating doses of intraperitoneal
Cisplatin (CDDP) in the treatment of patients with advanced peritoneal adenocarcinoma of
gastrointestinal origin.

Inclusion Criteria


Patients age greater than or equal to 18 years.

Patients with histologically proven gastrointestinal adenocarcinoma, mesothelioma, or
sarcoma. By standard staging studies there must be evidence of advanced or metastatic
intraabdominal disease. Patients with minimal extraabdominal metastatic disease and who
have symptoms exclusively referable to advanced intraabdominal malignancy will be
considered for the study. Specifically, patients with gastric cancer and bulky N-2 lymph
node involvement or patients with other primaries and who have malignant ascites or
peritoneal seeding would be considered optimal candidates. If all gross peritoneal
disease is resected (i.e., gross omental implants removed by gastrectomy), patients are
still eligible for treatment.

Patients must have recovered from any toxicity from all prior chemotherapy, immunotherapy,
or radiotherapy (30 days).

Patients must not have any significant systemic illness (e.g., infection, cardiovascular,
or pulmonary) which would preclude them from being an operative candidate.

patients must have a life expectancy of at least 8 weeks.

Performance status should be ECOG level 0, 1, or 2.

Patients must have adequate renal function (i.e., serum creatinine less than or equal to
2.0 or creatinine clearance of greater than or equal to 45 ml/min).

Patients must be HIV negative.

Women of child bearing age must not be pregnant or breast feeding.

Patients with prior CDDP will be eligible if there is no evidence of existing irreversible
CDDP toxicity. Patients suspected of having chronic CDDP toxicity will be further
evaluated as clinically indicated.

Patients may have mild elevations (less than 2.0 times normal) in liver function test if
the abnormalities are consistent with advanced intra-abdominal cancer.

Abnormalities (greater than 1 sec over normal) in PT or PTT or severe thrombocytopenia
(less than 75 K) will render patients ineligible.

A low Hgb secondary to chronic tumor-related, blood loss is acceptable if the patient is
willing and able to have transfusion.

Patients will be ineligible if the WBC is less than 3,000.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

930048

NCT ID:

NCT00001332

Start Date:

December 1992

Completion Date:

October 2000

Related Keywords:

  • Peritoneal Neoplasms
  • Stomach Neoplasms
  • Cancer Treatment
  • Chemotherapy
  • Regional Therapy
  • Surgery
  • Neoplasms
  • Fever
  • Stomach Neoplasms
  • Peritoneal Neoplasms
  • Carcinoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892