Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003172
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Comparison of Combination Chemotherapy Regimens in Treating Patients With Advanced Stomach Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Trial of Either 5-Fluorouracil Recombinant Alfa-2a-Interferon and Intravenous Hydroxyurea With Filgrastim Support FHIG or DoxorubicinDocetaxel Dd in Patients With Advanced Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2002-09
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 Giving drugs in different combinations and combining them with interferon alfa and G-CSF may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating patients with advanced stomach cancer
PURPOSE Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating patients with advanced stomach cancer
Detailed Description:
OBJECTIVES I Evaluate the objective response rates for two different regimens in patients with advanced gastric cancer the combination of fluorouracil plus hydroxyurea given as high dose 24 hour infusions plus interferon alfa-2a and filgrastim versus the combination of doxorubicin and docetaxel II Evaluate the toxicities and reversibility of toxicities of each of these combinations in patients with advanced gastric cancer
OUTLINE This is an open label two arm multicenter randomized study Arm I Patients receive fluorouracil 5-FU recombinant alfa-2a interferon hydroxyurea HU and filgrastim granulocyte colony-stimulating factor G-CSF 5-FU is administered by 24 hour infusion on days 1 8 15 22 29 and 36 weeks 1-6 Recombinant alfa-2a interferon is administered subcutaneously immediately before beginning the 5-FU infusion then three times a week for 6 weeks HU is administered by 24 hour infusion on days 1 8 15 22 29 and 36 weeks 1-6 G-CSF is administered subcutaneously on days 3 4 5 and 6 on weeks 1-6 Weeks 7 and 8 are rest periods Arm II Patients receive doxorubicin administered by slow IV push followed 30 minutes after infusion by docetaxel as a 1 hour IV infusion Treatment is repeated every 21 days All patients are assessed monthly during study and continue study treatment as long as no disease progression or unacceptable toxic effects are observed Patients are followed every 3 months for the first 2 years then every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL A minimum of 26 patients 13 in each arm and a maximum of 80 patients 40 in each arm will be accrued in this study in approximately 2 years
OUTLINE This is an open label two arm multicenter randomized study Arm I Patients receive fluorouracil 5-FU recombinant alfa-2a interferon hydroxyurea HU and filgrastim granulocyte colony-stimulating factor G-CSF 5-FU is administered by 24 hour infusion on days 1 8 15 22 29 and 36 weeks 1-6 Recombinant alfa-2a interferon is administered subcutaneously immediately before beginning the 5-FU infusion then three times a week for 6 weeks HU is administered by 24 hour infusion on days 1 8 15 22 29 and 36 weeks 1-6 G-CSF is administered subcutaneously on days 3 4 5 and 6 on weeks 1-6 Weeks 7 and 8 are rest periods Arm II Patients receive doxorubicin administered by slow IV push followed 30 minutes after infusion by docetaxel as a 1 hour IV infusion Treatment is repeated every 21 days All patients are assessed monthly during study and continue study treatment as long as no disease progression or unacceptable toxic effects are observed Patients are followed every 3 months for the first 2 years then every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL A minimum of 26 patients 13 in each arm and a maximum of 80 patients 40 in each arm will be accrued in this study in approximately 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 |
|---|---|---|---|
| E-6296 | None | None | None |