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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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). 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 |
What the finished NCT00001569 record still lists
NCT00001569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00001569 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001569's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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