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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001332
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
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.

Condition Intervention Phase
Peritoneal Neoplasms Stomach Neoplasms Procedure: CHPP with cisplatin Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 50
Study Start Date: December 1992
Estimated Study Completion Date: October 2000
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001332


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001332     History of Changes
Other Study ID Numbers: 930048
93-C-0048
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: November 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Cancer Treatment
Chemotherapy
Regional Therapy
Surgery

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Fever
Stomach Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Body Temperature Changes
Signs and Symptoms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Abdominal Neoplasms
Peritoneal Diseases