Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480584
Status:
COMPLETED
Last Update Posted:
2012-11-08
First Post:
2007-05-29
Brief Title:
A Phase I Trial of Capecitabine in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase I Trial of GemCap-T Capecitabine in Combination With Gemcitabine and Erlotinib Tarceva in Patients With Advanced Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2012-11
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:
This is a phase I clinical trial examining the safety feasibility and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma
Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine once per week for 3 weeks followed by a week off treatment Erlotinib tablet taken by mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period An accelerated dose-escalation scheme will be employed with 4 planned dose levels Whenever patients have been enrolled at a given dose with at most 1 DLT the protocol will be stopped and the dose will be called the maximum tolerated dose MTD Patients will be treated at the recommended phase II dose RPTD to confirm tolerability at that dose
In the absence of treatment delays due to adverse events treatment may continue for 6 cycles or until disease progression and patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity
Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine once per week for 3 weeks followed by a week off treatment Erlotinib tablet taken by mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period An accelerated dose-escalation scheme will be employed with 4 planned dose levels Whenever patients have been enrolled at a given dose with at most 1 DLT the protocol will be stopped and the dose will be called the maximum tolerated dose MTD Patients will be treated at the recommended phase II dose RPTD to confirm tolerability at that dose
In the absence of treatment delays due to adverse events treatment may continue for 6 cycles or until disease progression and patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity
Detailed Description:
This is a phase I clinical trial examining the safety feasibility and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma This combination of drugs has never been used before
Screening tests will consists of demographics a medical history and physical exam vital signs height weight performance status blood counts chemistries and clotting There will also be an electrocardiogram EKG tumor measurement computed tomography CT Scan or magnetic resonance imaging MRI or positron emission tomography CT PET-CT cancer antigen CA 19-9 and a serum pregnancy test for women of childbearing potential Tumor measurements are also performed after cycle 2 4 and 6 study end
Treatment will be administered on an outpatient basis and consists of both intravenous IV medication and tablets taken by mouth The gemcitabine will be administered at Moffitt once per week for 3 weeks followed by a week off treatment One tablet of erlotinib will be taken by mouth continuously starting with day one of cycle 1 while capecitabine will be taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period This set of treatments is called a cycle One full cycle of treatment will last 28 days and a total of 6 cycles of treatments are planned Before each cycle we will repeat the blood counts and a brief physical exam vital signs will be recorded weekly during the first 3 weeks of the 28 day cycle of treatment when receiving Gemcitabine
An accelerated dose-escalation scheme will be employed with 4 planned dose levels Patients will be enrolled at the lowest dosage level if no patients have unacceptable toxicity the dose will be escalated and additional patients enrolled If one of the patients at a given dose level experiences a dose limiting toxicity DLT more patients will be treated at that dose level When 2 patients have DLTs at the same dose the dose will be deescalated to the previous dose and additional patients will be enrolled After de-escalation begins whenever patients have been enrolled at a given dose with at most 1 DLT the protocol will be stopped and the dose will be called the maximum tolerated dose MTD Patients will be treated at the recommended phase II dose RPTD to confirm tolerability at that dose
In the absence of treatment delays due to adverse events treatment may continue for 6 cycles or until disease progression Patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity
Screening tests will consists of demographics a medical history and physical exam vital signs height weight performance status blood counts chemistries and clotting There will also be an electrocardiogram EKG tumor measurement computed tomography CT Scan or magnetic resonance imaging MRI or positron emission tomography CT PET-CT cancer antigen CA 19-9 and a serum pregnancy test for women of childbearing potential Tumor measurements are also performed after cycle 2 4 and 6 study end
Treatment will be administered on an outpatient basis and consists of both intravenous IV medication and tablets taken by mouth The gemcitabine will be administered at Moffitt once per week for 3 weeks followed by a week off treatment One tablet of erlotinib will be taken by mouth continuously starting with day one of cycle 1 while capecitabine will be taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period This set of treatments is called a cycle One full cycle of treatment will last 28 days and a total of 6 cycles of treatments are planned Before each cycle we will repeat the blood counts and a brief physical exam vital signs will be recorded weekly during the first 3 weeks of the 28 day cycle of treatment when receiving Gemcitabine
An accelerated dose-escalation scheme will be employed with 4 planned dose levels Patients will be enrolled at the lowest dosage level if no patients have unacceptable toxicity the dose will be escalated and additional patients enrolled If one of the patients at a given dose level experiences a dose limiting toxicity DLT more patients will be treated at that dose level When 2 patients have DLTs at the same dose the dose will be deescalated to the previous dose and additional patients will be enrolled After de-escalation begins whenever patients have been enrolled at a given dose with at most 1 DLT the protocol will be stopped and the dose will be called the maximum tolerated dose MTD Patients will be treated at the recommended phase II dose RPTD to confirm tolerability at that dose
In the absence of treatment delays due to adverse events treatment may continue for 6 cycles or until disease progression Patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity
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 |
|---|---|---|---|
| OSI3482s | OTHER | Genentech | None |