Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Solid Neoplasm
Pancreatic Acinar Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 metastati...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 with or without gemcitabine hydrochloride in patients with unresectable soli...
Eligibility Criteria
Inclusion
- 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")
- Tubal ligation
- Partner's vasectomy
- Intrauterine device (IUD) (non-progesterone T)
- Vaginal sponge (containing spermicide)
- 100% commitment to abstinence
- Unacceptable forms of contraception for women of childbearing potential:
- Oral contraception containing progestins only
- IUD progesterone T
- Female condom
- Natural family planning (rhythm method) or breastfeeding
- Fertility awareness
- Withdrawal
- Cervical shield
- Willing to abstain from smoking
- Willing to complete a daily pill diary
Exclusion
- Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any of the following prior therapies:
- Chemotherapy =\< 4 weeks prior to registration
- Mitomycin C/nitrosoureas =\< 6 weeks prior to registration
- Immunotherapy =\< 4 weeks prior to registration
- Biologic therapy =\< 4 weeks prior to registration
- Radiation therapy =\< 4 weeks prior to registration
- Radiation to \> 25% of bone marrow
- Failure to fully recover from acute, reversible effects of prior therapy regardless of interval since last treatment
- New York Heart Association classification III or IV
- Seizure disorder
- Central nervous system (CNS) metastases if not stable for at least 2-3 months based on imaging, clinical assessment, and use of steroids, or seizure disorder
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception until 12 months after last study drug dose
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
- Current therapy with a CYP3A4 inhibitor or inducer
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients receiving highly active antiretroviral therapy (HAART) treatment
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
- History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- More than 2 prior chemotherapy regimens for the current metastatic malignancy; full dose chemotherapy used in conjunction with concurrent radiation therapy will be included as prior therapy; Note: prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, tamoxifen) will be allowed and not included as a prior chemotherapy
- Previous therapy with a hedgehog inhibitor
Key Trial Info
Start Date :
March 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00878163
Start Date
March 31 2009
End Date
March 6 2026
Last Update
September 9 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
3
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905