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

Primary Purpose

Peritoneal Neoplasms, Stomach Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CHPP with cisplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Neoplasms focused on measuring Cancer Treatment, Chemotherapy, Regional Therapy, Surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001332
Brief Title
Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis
Official Title
Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
December 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Neoplasms, Stomach Neoplasms
Keywords
Cancer Treatment, Chemotherapy, Regional Therapy, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
CHPP with cisplatin

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3775075
Citation
Wisbeck WM, Becher EM, Russell AH. Adenocarcinoma of the stomach: autopsy observations with therapeutic implications for the radiation oncologist. Radiother Oncol. 1986 Sep;7(1):13-8. doi: 10.1016/s0167-8140(86)80120-7.
Results Reference
background
PubMed Identifier
2609913
Citation
Eggermont AM, Sugarbaker PH. Efficacy of intracavitary administration of cyclophosphamide, interleukin-2 and lymphokine activated killer cells against established intraperitoneal tumor. Acta Med Austriaca. 1989;16(3-4):47-50.
Results Reference
background
PubMed Identifier
2692376
Citation
Knusli C, Ruff P, Laffer U, Stoll HR, Obrist R, Weber W, Obrecht JP. Intraperitoneal chemotherapy in peritoneal malignancy: impact of intensive system care on practicability. Acta Med Austriaca. 1989;16(3-4):70-3.
Results Reference
background

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

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