NCT00480584

A Phase I Trial of Capecitabine in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer

A Phase I Trial of GemCap-T, Capecitabine in Combination With Gemcitabine and Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Metastatic Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	gemcitabine	Levels 1 through 4: 1000 mg/m\^2
DRUG	capecitabine	Level 1: 500 mg/m\^2; Level 2: 825 mg/m\^2; Level 3: 1000 mg/m\^2; Level 4: 1250 mg/m\^2
DRUG	erlotinib	Levels 1 through 4: 100 mg

Timeline

• Start date: 2007-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2007-05-31
• Last updated: 2012-11-08

Locations

1 site across 1 country: United States