|
Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy Clinical research trials and Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy. Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy  Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy
Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy
For Condition: Abdominal Neoplasm,Colonic Neoplasm,Peritoneal Neoplasm,Mesothelioma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will test the effectiveness of an experimental treatment for peritoneal cancer involving surgical removal of the tumor, perfusion of the abdomen during surgery with a heated solution of the drug cisplatin, and post-surgery combination chemotherapy. Patients with peritoneal cancer whose tumor is confined to the abdomen may be eligible for this study. Candidates will be screened with a medical history and physical examination including blood tests, electrocardiogram, and possibly bone scan, brain magnetic resonance imaging, and chest, abdomen and pelvic CT scans. Those enrolled in the study will undergo surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected. During surgery, after the tumor has been removed, two catheters (thin plastic tubes) will be placed in the abdomen. A chemotherapy solution containing the anti-cancer drug cisplatin heated to a temperature of about 108.6 degrees (10 degrees above normal body temperature) will then be delivered into the abdomen through one catheter and drained through another. After 90 minutes of bathing the abdomen with this solution, the drug will be rinsed from the abdomen and the catheters removed. Another small catheter will then be placed and left inside the abdomen with one end coming out through the skin. Two to 10 days after the operation, the drugs fluorouracil (5-FU) and paclitaxel will be given through this catheter. After complete recovery from the surgery, the catheter will be removed and the patient discharged from the hospital. Clinic visits will be scheduled for periodic follow-up examination and tests. Patients in this study will also be asked to assess how this therapy affects their general health and well being. This will require filling out two quality-of-life questionnaires before surgery and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to complete.
Details: Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of peritoneal carcinomatosis. The purpose of this study is to examine the treatment results of continuous hyperthermic peritoneal perfusion with cisplatin plus early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel after cytoreductive surgery for peritoneal carcinomatosis. Results will be assessed by following the time to radiographic or clinical recurrence of disease and survival. Patients will be stratified for entry based on histology. This will include 3 cohorts: 1) peritoneal mesothelioma; 2) low grade mucinous adenocarcinoma (including low grade mucinous neoplasms of borderline malignant potential); and 3) adenocarcinoma of gastrointestinal origin (other than low grade mucinous).
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: The patient must have histologically proven peritoneal carcinomatosis from the following histologies: primary peritoneal mesothelioma; low grade mucinous adenocarcinoma (including low grade mucinous neoplasms of borderline malignant potential); adenocarcinoma of gastrointestinal tract origin (other than low grade mucinous, excluding pancreatic cancer). Radiologic workup must demonstrate that the disease is confined to the peritoneal cavity. Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less that 1 cm in diameter per tumor deposit. Patients must have an ECOG performance status of less than or equal to 2. Patients must have a minimum expected duration of survival of greater than 8 weeks. Patients must have recovered from any toxicity from all prior chemotherapy, immunotherapy or radiotherapy and be at least 30 days past the date of their last treatment. EXCLUSION CRITERIA: Patients will be excluded if they have concomitant medical problems that would place them at unacceptable risk for a major surgical procedure. Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., age greater than 65, history of hypertension, first degree relative with atherosclerotic coronary artery disease) will undergo cardiac evaluation and will not be eligible if they demonstrate significant irreversible ischemia on a stress thallium study or an injection fraction of less than 40%. Patients who have shortness of breath with minimal exertion and who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will not be eligible if their FEV1 is less than 1.2 liters or their maximum voluntary ventilation is less than 50% of expected. Patients who have a baseline neurological toxicity of Grade 3 or greater will be excluded because of the potential neurotoxicity associated with platinum and paclitaxel therapy. Patients will be ineligible if they have a creatinine of greater than 1.5 or a creatinine clearance of less 70 mL/min. Patients will be ineligible if the WBC is less than 3000/microliters or platelets are less than 75,000/mm(3). Patients will be ineligible if the serum total bilirubin level or liver enzymes are greater than 2 times the upper limit of normal. Patients who have failed previous intraperitoneal platinum therapy will be ineligible. Treatment failure is defined as radiographic evidence of disease progression on two consecutive CT scans within 6 months of treatment. Pregnant women or women who are breast feeding will be ineligible. Patients less than 30 kg will be ineligible.
Total Enrollment: 128
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 000069; 00-C-0069
Study Start Date: January 28, 2000
Record last reviewed: January 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004547
Other Abdominal Neoplasm Studies:
1. Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy
2. Experimental Drug SS1(dsFv)-PE38 to Treat Cancer
3. Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion in Patients with Pulmonary and Pleural Malignancies
4. Study of Decitabine in Preventing Tumor Growth
Related Studies:
Other Abdominal Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy
|
|
|
|
|
|
|
|
