Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003055
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Cisplatin and Irinotecan in Treating Patients With Locally Advanced or Metastatic Esophageal or Gastric Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Cisplatin and Irinotecan in Patients With Advanced Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic esophageal or gastric cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with locally advanced or metastatic esophageal or gastric cancer
Detailed Description:
OBJECTIVES I Evaluate the response rate of combined cisplatin and irinotecan in patients with metastatic or locally advanced inoperable or recurrent esophageal or gastric cancer II Evaluate the toxic effects both qualitatively and quantitatively of cisplatin and irinotecan in these patients III Estimate the disease free and overall survival of these patients IV Assess whether the response proportion differs between squamous cell and adenocarcinoma of the esophagus V Evaluate quality of life issues using the Memorial Symptom Assessment Scale the FACT-G questionnaire and the dysphagia scale
OUTLINE Patients receive cisplatin and irinotecan on days 1 8 15 and 22 for 4 weeks followed by a 2 week rest period Each treatment course lasts 6 weeks Patients receive at least 3 courses of therapy if the treatment is well tolerated and no disease progression is documented Patients attaining a complete response receive additional courses of therapy at the discretion of the investigator Tumor status is reassessed at 6 weeks and every 12 weeks thereafter Patients are followed until death
PROJECTED ACCRUAL A total of 28-50 patients will be accrued within 12-18 months Accrual for adenocarcinoma of the esophagus is complete
OUTLINE Patients receive cisplatin and irinotecan on days 1 8 15 and 22 for 4 weeks followed by a 2 week rest period Each treatment course lasts 6 weeks Patients receive at least 3 courses of therapy if the treatment is well tolerated and no disease progression is documented Patients attaining a complete response receive additional courses of therapy at the discretion of the investigator Tumor status is reassessed at 6 weeks and every 12 weeks thereafter Patients are followed until death
PROJECTED ACCRUAL A total of 28-50 patients will be accrued within 12-18 months Accrual for adenocarcinoma of the esophagus is complete
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 |
|---|---|---|---|
| NCI-G97-1306 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065703 | REGISTRY | None | None |