Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003834
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum Per 0499 Amendment Old Title A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum Confined to the Liver
Status:
COMPLETED
Status Verified Date:
2016-07
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 liver metastases from colorectal cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy of treatment with oxaliplatin fluorouracil and leucovorin calcium in terms of the resectability rate in patients with unresectable advanced colorectal carcinoma confined to the liver II Assess this regimen in terms of response rate toxicity and overall survival in these patients
OUTLINE Patients receive oxaliplatin IV over 2 hours on day 1 then leucovorin calcium IV over 2 hours with fluorouracil IV bolus followed by fluorouracil IV over 22 hours on days 1 and 2 Courses repeat every 2 weeks Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable Patients who achieve complete response CR partial response PR with unresectable disease or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity Patients who demonstrate a response are treated until best response or until disease is deemed resectable Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator Patients are followed every 3 months for 1 year and then every 6 months for 2 years
OUTLINE Patients receive oxaliplatin IV over 2 hours on day 1 then leucovorin calcium IV over 2 hours with fluorouracil IV bolus followed by fluorouracil IV over 22 hours on days 1 and 2 Courses repeat every 2 weeks Patients with stable disease continue treatment in the absence of disease progression or unacceptable toxicity or until disease is resectable Patients who achieve complete response CR partial response PR with unresectable disease or PR but are not surgical candidates continue treatment in the absence of disease progression or unacceptable toxicity Patients who demonstrate a response are treated until best response or until disease is deemed resectable Patients who achieve a CR or PR and are resected may receive 2 to 4 additional courses of therapy at the discretion of the investigator Patients are followed every 3 months for 1 year and then every 6 months for 2 years
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 |
|---|---|---|---|
| CDR0000066991 | REGISTRY | PDQ Physician Data Query | None |