Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471484
Status:
UNKNOWN
Last Update Posted:
2011-06-22
First Post:
2007-05-08
Brief Title:
Combination Chemotherapy and Interferon Alfa-2b in Treating Patients With Nonmetastatic Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of OxaliplatinAdriamycin5 Fluorouracil in Continuous Infusion Interferon α-2b OXAFI Combination as Neoadjuvant Therapy in Unresectable Non-Metastatic Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
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 such as oxaliplatin doxorubicin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Interferon alfa may interfere with the growth of tumor cells Giving combination chemotherapy together with interferon alfa may kill more tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with interferon alfa-2b works in treating patients with nonmetastatic liver cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with interferon alfa-2b works in treating patients with nonmetastatic liver cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with unresectable nonmetastatic hepatocellular carcinoma treated with neoadjuvant oxaliplatin doxorubicin hydrochloride fluorouracil and recombinant interferon alfa-2b
Secondary
Determine the overall survival of patients treated with this regimen
Determine the progression-free survival of patients treated with this regimen
Determine the rate of conversion to resectability of tumor in patients treated with this regimen
Determine the toxicity profile of this regimen in these patients
Assess the quality of life of patients treated with this regimen
Correlate changes in serological markers of angiogenesis before and after treatment with clinical outcome in these patients
Correlate and validate the use of functional imaging before and after treatment with clinical outcome in these patients
OUTLINE Patients receive neoadjuvant OXAFI therapy comprising oxaliplatin IV and doxorubicin hydrochloride IV on days 1 8 and 15 fluorouracil IV continuously on days 1-28 and recombinant interferon alfa-2b subcutaneously three times weekly in weeks 1-4 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients receive at least 2 courses of neoadjuvant therapy before undergoing evaluation for response Patients whose disease becomes resectable after achieving a complete or partial response proceed to surgery Patients whose disease remains unresectable are reevaluated until their disease either becomes resectable they complete neoadjuvant therapy or they meet discontinuation criteria
At least 2 weeks after receiving neoadjuvant therapy patients whose disease is resectable undergo surgery for potentially complete resection of their tumors with curative intent Patients who achieve complete resection proceed to adjuvant therapy
At least 4 weeks after surgery patients may restart OXAFI as adjuvant therapy provided they have fully recovered from surgery and have received fewer than 6 courses of neoadjuvant therapy Adjuvant therapy repeats every 28 days for a total of 6 courses including neoadjuvant OXAFI in the absence of disease progression or unacceptable toxicity
Patients undergo blood and tissue collection at baseline and periodically during study for evaluation of circulating and tissue biomarkers of angiogenesis Serum from venous blood samples is analyzed for concentration of VEGF by ELISA Tumor tissue obtained before and after treatment is examined for tumor VEGF expression microvessel density and cellular proliferation by IHC
Patients complete quality of life questionnaires at baseline monthly during study treatment after course 6 of neoadjuvant chemotherapy or upon discontinuation of study treatment
Patients are followed periodically for up to 5 years after curative resection of their tumors
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study
Primary
Determine the response rate in patients with unresectable nonmetastatic hepatocellular carcinoma treated with neoadjuvant oxaliplatin doxorubicin hydrochloride fluorouracil and recombinant interferon alfa-2b
Secondary
Determine the overall survival of patients treated with this regimen
Determine the progression-free survival of patients treated with this regimen
Determine the rate of conversion to resectability of tumor in patients treated with this regimen
Determine the toxicity profile of this regimen in these patients
Assess the quality of life of patients treated with this regimen
Correlate changes in serological markers of angiogenesis before and after treatment with clinical outcome in these patients
Correlate and validate the use of functional imaging before and after treatment with clinical outcome in these patients
OUTLINE Patients receive neoadjuvant OXAFI therapy comprising oxaliplatin IV and doxorubicin hydrochloride IV on days 1 8 and 15 fluorouracil IV continuously on days 1-28 and recombinant interferon alfa-2b subcutaneously three times weekly in weeks 1-4 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients receive at least 2 courses of neoadjuvant therapy before undergoing evaluation for response Patients whose disease becomes resectable after achieving a complete or partial response proceed to surgery Patients whose disease remains unresectable are reevaluated until their disease either becomes resectable they complete neoadjuvant therapy or they meet discontinuation criteria
At least 2 weeks after receiving neoadjuvant therapy patients whose disease is resectable undergo surgery for potentially complete resection of their tumors with curative intent Patients who achieve complete resection proceed to adjuvant therapy
At least 4 weeks after surgery patients may restart OXAFI as adjuvant therapy provided they have fully recovered from surgery and have received fewer than 6 courses of neoadjuvant therapy Adjuvant therapy repeats every 28 days for a total of 6 courses including neoadjuvant OXAFI in the absence of disease progression or unacceptable toxicity
Patients undergo blood and tissue collection at baseline and periodically during study for evaluation of circulating and tissue biomarkers of angiogenesis Serum from venous blood samples is analyzed for concentration of VEGF by ELISA Tumor tissue obtained before and after treatment is examined for tumor VEGF expression microvessel density and cellular proliferation by IHC
Patients complete quality of life questionnaires at baseline monthly during study treatment after course 6 of neoadjuvant chemotherapy or upon discontinuation of study treatment
Patients are followed periodically for up to 5 years after curative resection of their tumors
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SPRI-SINGAPORE-OC-GI-01-06 | None | None | None |
| SINGAPORE-OC-GI-01-06 | None | None | None |
| SINGAPORE-IRB-06-16-HEP | None | None | None |
| SINGAPORE-CTC0600327 | None | None | None |