Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003001
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
Stony Brook University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of 5-FluorouracilFolinic AcidGemcitabine in Patients With Advanced Colorectal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2002-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 III trial to study the effectiveness of combination chemotherapy consisting of fluorouracil leucovorin and gemcitabine in treating patients with recurrent or metastatic colorectal cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy consisting of fluorouracil leucovorin and gemcitabine in treating patients with recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Determine the response rate and survival of patients with recurrent or metastatic colorectal carcinoma treated with fluorouracil 5-FU leucovorin calcium and gemcitabine II Evaluate and establish the toxic effect profile of 5-FU leucovorin calcium and gemcitabine in these patients
OUTLINE This is a dose escalation study Patients receive intravenous leucovorin calcium for 60 minutes and bolus infusions of fluorouracil 5-FU followed by gemcitabine infusions weekly for six weeks followed by 2 weeks of rest The dosage of gemcitabine is increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities Phase II proceeds at the maximum tolerated dose 1 dose level below that at which 3 patients experience grade 3-4 toxicities Patients receive a minimum of two courses of treatment to be considered evaluable for response Patients with stable disease partial or complete remission may continue therapy for up to six treatment cycles Patients exhibiting disease progression or intolerable toxic effects are removed from the study
PROJECTED ACCRUAL A total of 63 patients will be accrued
OUTLINE This is a dose escalation study Patients receive intravenous leucovorin calcium for 60 minutes and bolus infusions of fluorouracil 5-FU followed by gemcitabine infusions weekly for six weeks followed by 2 weeks of rest The dosage of gemcitabine is increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities Phase II proceeds at the maximum tolerated dose 1 dose level below that at which 3 patients experience grade 3-4 toxicities Patients receive a minimum of two courses of treatment to be considered evaluable for response Patients with stable disease partial or complete remission may continue therapy for up to six treatment cycles Patients exhibiting disease progression or intolerable toxic effects are removed from the study
PROJECTED ACCRUAL A total of 63 patients will be accrued
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-V97-1256 | None | None | None |
| SUNY-HSC-97-2824 | None | None | None |