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Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis Clinical research trials and Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis. Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis  Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis
Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis
For Condition: Peritoneal Neoplasms,Stomach Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 50
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 930048; 93-C-0048
Study Start Date: December 9, 1992
Record last reviewed: November 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001332
Other Peritoneal Neoplasms Studies:
1. Tezacitabine with or without 5-Fluorouracil (5-FU) for advanced esophageal cancer or gastric cancer
2. A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery
3. Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Dose I.P. Platinum for Gastrointestinal Peritoneal Carcinomatosis
4. A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
5. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
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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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