Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262808
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2005-12-06
Brief Title:
GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A PHASE II Study of GM-CSF As Pre- And Post-operative Adjuvant Therapy For Stage II And III Colon Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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 Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy or kill tumor cells Drugs used in chemotherapy such as fluorouracil leucovorin and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Giving combination chemotherapy after surgery may kill any remaining tumor cells Sometimes after surgery the tumor may not need additional treatment until it progresses In this case observation may be sufficient
PURPOSE This phase II trial is studying how well GM-CSF and combination chemotherapy work in treating patients who are undergoing surgery for stage II or stage III colon cancer
PURPOSE This phase II trial is studying how well GM-CSF and combination chemotherapy work in treating patients who are undergoing surgery for stage II or stage III colon cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of neoadjuvant and adjuvant sargramostim GM-CSF and adjuvant chemotherapy in patients with resectable stage II or III colon cancer
Determine the efficacy in terms of enhanced tumor-associated macrophage response of this regimen in these patients
Secondary
Determine overall survival and time to progression in patients treated with this regimen
OUTLINE
Neoadjuvant therapy and surgery Patients receive sargramostim GM-CSF subcutaneously SC once daily beginning between days -16 and -12 and continuing until day -1 Patients undergo surgical resection on day 0 Patients with stage I or IV disease are removed from the study All other patients proceed to adjuvant chemotherapy or observation
Adjuvant chemotherapy or observation Patients with high-risk stage II or any stage III disease are assigned to group 1 or 2 Patients with low-risk stage II disease are assigned to group 3
Group 1 adjuvant therapy for high-risk stage II disease Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV on days 1 8 15 22 29 and 36 Patients also receive GM-CSF SC once daily on days 50-54 Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Group 2 adjuvant therapy for stage III disease Patients receive adjuvant chemotherapy and GM-CSF as in group 1 Alternatively patients may receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1 These patients also receive GM-CSF SC once daily on days 10-14 of every fourth course Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Group 3 low-risk stage II disease Patients undergo observation only every 3 months
After completion of study treatment patients are followed periodically for survival
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the safety of neoadjuvant and adjuvant sargramostim GM-CSF and adjuvant chemotherapy in patients with resectable stage II or III colon cancer
Determine the efficacy in terms of enhanced tumor-associated macrophage response of this regimen in these patients
Secondary
Determine overall survival and time to progression in patients treated with this regimen
OUTLINE
Neoadjuvant therapy and surgery Patients receive sargramostim GM-CSF subcutaneously SC once daily beginning between days -16 and -12 and continuing until day -1 Patients undergo surgical resection on day 0 Patients with stage I or IV disease are removed from the study All other patients proceed to adjuvant chemotherapy or observation
Adjuvant chemotherapy or observation Patients with high-risk stage II or any stage III disease are assigned to group 1 or 2 Patients with low-risk stage II disease are assigned to group 3
Group 1 adjuvant therapy for high-risk stage II disease Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV on days 1 8 15 22 29 and 36 Patients also receive GM-CSF SC once daily on days 50-54 Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Group 2 adjuvant therapy for stage III disease Patients receive adjuvant chemotherapy and GM-CSF as in group 1 Alternatively patients may receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1 These patients also receive GM-CSF SC once daily on days 10-14 of every fourth course Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Group 3 low-risk stage II disease Patients undergo observation only every 3 months
After completion of study treatment patients are followed periodically for survival
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| DUMC-7135-05-5R0 | None | None | None |
| URCC-U1203 | None | None | None |
| URCC-RSRB-09956 | None | None | None |
| BRLX-001-0837 | None | None | None |