GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patien… (NCT00878163) | Clinical Trial Compass
Active — Not RecruitingPhase 1
GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery
United States55 participantsStarted 2009-03-31
Plain-language summary
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with erlotinib hydrochloride with or without gemcitabine hydrochloride may kill more tumor cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic proof of a solid tumor that is now unresectable, not amenable to any other standard therapies, or patient refuses standard therapy
* Metastatic adenocarcinoma of the pancreas amenable to biopsies (cohort II MTD only)
* Absolute neutrophil count (ANC) \>= 1,500/μL
* Platelets \>= 100,000/μL
* Total bilirubin =\< upper limit of normal (ULN)
* Aspartate aminotransferase (AST) =\< 3 times upper limit of normal (ULN)
* Creatinine =\< 1.5 times ULN
* Hemoglobin \>= 9.0 g/dL
* International Normalized Ratio (INR) within normal limits (for patients treated at the MTD)
* Ability to provide informed consent
* Willingness to return to Mayo Clinic for follow up
* Life expectancy \>= 12 weeks
* Willingness to provide the biologic specimens as required by the protocol
* Negative serum pregnancy test done =\< 7 days prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Able to swallow or have medication administered through a G-tube and absorb the medication
* Participant agrees to use an acceptable form of contraception; acceptable forms of contraception:
* Latex condom (always used with spermicide)
* Diaphragm (always used with spermicide)
* Cervical cap (always used with spermicide)
Acceptable forms of secondary contraceptions, when used along with a barrier method:
* Hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e. "Mini-pill"…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of erlotinib hydrochloride defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients