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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001569 |
Two days prior to planned surgery, paclitaxel is infused IV over 24 hours.
Patients will undergo cytoreductive surgery, to debulk tumor. Scope of procedure will vary with each patient, including a spectrum of possible procedures, such as splenectomy, liver resection, pancreatic resection or bowel resection.
After cytoreductive surgery, continuous hyperthermic peritoneal perfusion (CHPP) surgery with cisplatin will begin by placing an influx and efflux catheters via abdominal wall. Perfusion rate of cisplatin is 1.5 L/min and the duration is 90 min.
Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery.
Dose escalation will proceed after patients at a given dose level receive 3 courses. In order to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose escalation. MTD is either the dose level immediately below the level at which 2 of 6 patients in a cohort experience nonhematologic dose limiting toxicity (DLT) or when 4 of 6 patients experience hematologic DLT.
Two to 4 months after surgery, laparotomy will be conducted to determine response to treatment. If tumor size is decreased, patients will undergo a second treatment course identical to the same techniques and chemotherapy agents.
Condition | Intervention | Phase |
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Carcinoma Peritoneal Neoplasm |
Drug: Cisplatin Drug: Paclitaxel Drug: 5-FU |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis |
Estimated Enrollment: | 74 |
Study Start Date: | January 1997 |
Estimated Study Completion Date: | December 2002 |
Peritoneal carcinomatosis is considered a terminal stage of tumor progression. Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of this disease. This study will define the maximum tolerated dose of paclitaxel and 5-fluorouracil (5-FU) given as an early post-operative intraperitoneal (IP) dwell therapy after cytoreductive surgery and continuous hyperthermic peritoneal perfusion with cisplatin (CHPP).
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The patients must have an ECOG performance status of 0 or 1 and have no concomitant medical problems that would place them at increased risk for a major surgical procedure (EG, cardiac or pulmonary disabilities).
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 performed which will include an attempt to remove all disease greater than 0.5 cm in diameter.
Study ID Numbers: | 970072, 97-C-0072 |
Study First Received: | November 3, 1999 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00001569 |
Health Authority: | United States: Federal Government |
Gastrointestinal Adenocarcinoma Taxol |
Digestive System Neoplasms Abdominal Neoplasms Carcinoma Fever Digestive System Diseases Cisplatin Paclitaxel |
Fluorouracil Peritoneal Diseases Gastrointestinal Neoplasms Peritoneal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |