Clinical trial NCT00640978
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer Advanced Pancreatic Cancer Unresectable Metastatic RAD001 Everolimus Erlotinib OSI-774 Erlotinib Hydrochloride Tarceva
Sponsor: M.D. Anderson Cancer Center
Start date: 2008-03-01; Completion date: 2010-03-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if the combination of RAD001 and erlotinib hydrochloride can slow the growth of advanced pancreatic cancer. The safety of this drug combination will also be studied.

Primary Objectives:

-Determine the overall survival (OS) at 6 months of the combination of erlotinib and RAD001 in patients who have received previous treatment for advanced pancreatic cancer.

Secondary Objectives:

* Determine the progression-free survival (PFS).
* Determine the response rate (RR).

Detailed description:
The Study Drugs:

RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.

Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take erlotinib hydrochloride by mouth every day of each 28-day study "cycle". You should take erlotinib hydrochloride once a day in the morning with 1 cup (about 8 oz.) of water. Erlotinib hydrochloride should be taken at least 1 hour before or 2 hours after you have any food, vitamins, iron supplements, or other non-prescription drugs.

On Days 1, 8, 15, and 22 of each cycle, you will take RAD001 by mouth in the morning. You should either take the study drug on an empty stomach with 2 cups (about 16 oz.) of water or after a low-fat meal. You should not take the study drug after large fatty meals because fatty meals lower the amount of the study drug in your body. Some examples of a low-fat meal include cereal with fat-free milk, a low-fat muffin, toast, or a bagel with fat-free spread, or fruit salad.

On days when you take both RAD001 and erlotinib hydrochloride, RAD001 should be taken right before erlotinib hydrochloride.

If you experience intolerable side effects, you must call your doctor right away. The doctor may tell you to stop taking the study drugs or to take fewer pills. The study drugs may also be stopped completely, if your doctor thinks it is necessary.

Study Visits:

On Day 1 of every cycle, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* You will have a performance status evaluation.
* Blood (about 2 tablespoons) and urine will for collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
* You will be asked about any drugs you may be taking or have taken since your last visit.

On Day 8 of Cycle 1, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* Blood (about 2 tablespoons) and urine will be collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
* You will be asked about any drugs you may be taking or have taken since your last visit.

At the end of every even cycle (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan to check the status of the disease. The scans will be the same type that you had during screening.

Length of Study:

You may remain on study as long as you are benefitting. You will be taken off study early if the disease gets worse, you have intolerable side effects, or if your doctor decides that it is in your best interest to stop treatment.

End-of-Study Visit:

About 14 days after the last dose of study drug, you will have an end-of-study visit. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* You will have a performance status evaluation.
* Blood (about 2-3 tablespoons) and urine will be collected for routine tests. You should be fasting at the time of the blood draw. You should not eat or drink anything except water after midnight the night before.
* If you have not had them within the last 4 weeks, you will have a CT or MRI scan to check the status of the disease. The scans will be the same type that you had during screening.

Long-Term Follow-Up:

After you go off study, you will be asked how you are doing once a month for the first 6 months from the beginning of the study treatment. Then you will be asked how you are doing every 3 months from then on. This may be done either by phone contact or a clinic visit and will take about 15-30 minutes.

This is an investigational study. Erlotinib hydrochloride in combination with gemcitabine is commercially available and FDA approved for the treatment of pancreatic cancer. RAD001 is not FDA approved or commercially available. At this time, the combination of these drugs is only being used in research.

Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
Interventions: intervention 1: RAD001 intervention 2: Erlotinib
Intervention descriptions: intervention 1: 30 mg orally weekly for 4 weeks intervention 2: 150 mg by mouth daily for 28 Days

Protocol documents: