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NCT00001569 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT00001569: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001569 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 74 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001569, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Cisplatin
- DRUG Paclitaxel
- DRUG 5-FU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 1997-01 |
| Est. Completion | 2002-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001569
The ClinicalTrials.gov registry entry for NCT00001569 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00001569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001569 about?
NCT00001569 is a clinical study titled "Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis". 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 r...
What is the current status of trial NCT00001569?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 1997-01. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00001569?
The interventions under investigation include: Cisplatin (DRUG), Paclitaxel (DRUG), 5-FU (DRUG).
Who is sponsoring clinical trial NCT00001569?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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