Clinical trial NCT00826449
Conditions: Lung Cancer Non-Small Cell Lung Cancer
Keywords: Advanced Solid Tumors Advanced Cancer Non-Small Cell Lung Cancer NSCLC Solid Tumor Malignancy Dasatinib BMS-354825 Sprycel® Erlotinib Erlotinib hydrochloride Tarceva OSI-774
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-02-01; Completion date: 2014-06-01
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of the Phase I portion of this study is to find the highest tolerable dose of the combination of dasatinib and erlotinib hydrochloride that can be given to patients with advanced solid tumors.

The goal of the Phase II portion of this study is to learn if this combination is effective when given to patients with non-small cell lung cancer.

The safety of this combination will be studied in both phases.

Detailed description:
The Study Drugs:

Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This 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. Blocking the protein may control tumor growth and survival. This may stop tumors from growing.

Study Groups:

If you are found to be eligible to participate in this study, you will be assigned to a study group based on when you joined this study. Up to 6 groups of 3-6 participants each will be enrolled in the Phase I portion of the study, and up to 35 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of dasatinib you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of dasatinib. Each new group will receive a higher dose of dasatinib than the group before it, if no intolerable side effects were seen. If intolerable side effects are seen, the next group of participants may receive the same dose level or a lower dose level. This will continue until the highest tolerable dose of dasatinib is found.

If you are enrolled in the Phase II portion, you will receive highest tolerated dose level of dasatinib that was found in the Phase I portion.

All participants will receive the same dose level of erlotinib hydrochloride. If the doctor thinks it is needed, the dose level may be lowered.

Study Drug Administration:

If you are in Phase I, on Day -3 of Cycle 1 (3 days before your first dose of study drugs), you will take erlotinib hydrochloride by mouth. On Days 1-19 of Cycle 1, you will be take dasatinib and erlotinib hydrochloride by mouth once a day. On Days 20 and 21 of Cycle 1, you will only take dasatinib by mouth once a day. Every day of Cycles 2 and beyond, you will take dasatinib and erlotinib hydrochloride by mouth once a day.

If you are in Phase II, every day you will take dasatinib and erlotinib hydrochloride by mouth once a day.

Each cycle is 21 days.

Erlotinib hydrochloride and dasatinib should be taken together at the same time every day. The tablets must be swallowed whole and may not be broken. The tablets should be taken with 1 cup (about 8 ounces) of water. Dasatinib and erlotinib hydrochloride should be taken 1 hour before or 2 hours after meals or any other drugs, and should not be taken with grapefruit juice. The entire dose must be taken at 1 time. If you vomit within 30 minutes of swallowing the tablets, the dose may be replaced if the tablets can be seen and counted. If you are currently taking St. John's Wort, you should stopping taking if for at least 5 days before taking dasatinib.

Study Visits:

At Week 1 of Cycle 1, your vital signs and weight will be measured.

At the end of Week 3 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 1 tablespoon) will be drawn for routine tests
* The amount of oxygen in your blood will be measured by a pulse oximeter.
* You will have a chest x-ray to check the status of the disease.
* You will be asked if you have experienced any side effects and to list any drugs you may be taking.
* Women who are able to become pregnant must have a negative blood (about 1-2 teaspoons) or urine pregnancy test.

At the end of Week 3 of Cycles 1 and 3, you will also have an ECG.

At the end of Week 3 of every other cycle (Cycles 2, 4, 6, and so on), you will also have a chest CT scan or a whole body PET/CT (if necessary) to check the status of the disease.

Phase I PK Testing:

If you are in Phase I, you will have blood (about 2 teaspoons each time) drawn for PK testing.

* On Day -3 of Cycle 1, blood will be drawn 5 different times.
* On Days -2, -1, and 1 of Cycle 1, blood will be drawn 1 time.
* On Day 19 of Cycle 1, blood will be drawn 5 times.
* On Days 20, 21, and 22 of Cycle 1, blood will be drawn 1 time.

Length of Study:

You may stay on study for as long as you are benefitting. You will be taken off study if you experience intolerable side effects or the disease gets worse.

End-of-Study Visit:

At the end of your study participation, you will have an end-of-study visit. At this 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 1 tablespoon) will be drawn for routine tests.
* The amount of oxygen in your blood will be measured.
* You will have a chest x-ray to check the status of the disease.
* You will have an ECG.

If you are taken off study due to unacceptable side effects, you will be called and asked about any side effects until the side effect gets better or becomes stable.

Long-Term Follow-Up:

After the end-of-study visit, you will be contacted every 3-4 months for 1 year to collect information about how you are doing. You (or your family members or designees) may be contacted by telephone or during clinic visits. If you are called, this will take about 5 minutes.

This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of acute lymphoid and chronic myeloid leukemia. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of non-small cell lung cancer. The use of this combination in this study is investigational.

Up to 59 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: Dasatinib + Erlotinib
Interventions: intervention 1: Dasatinib intervention 2: Erlotinib
Intervention descriptions: intervention 1: Starting dose of 70 mg by mouth daily for 21 day cycle. intervention 2: 150 mg by mouth daily every 21 day cycle.

Protocol documents: