Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001332
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I Study of Continuous Hyperthermic Peritoneal Perfusion CHPP With Escalating Dose IP Platinum for Gastrointestinal Peritoneal Carcinomatosis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of Continuous Hyperthermic Peritoneal Perfusion CHPP With Escalating Dose IP Platinum for Gastrointestinal Peritoneal Carcinomatosis
Status:
COMPLETED
Status Verified Date:
1999-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-C-0048 | None | None | None |