AZD0530 and Gemcitabine in Locally Advanced/Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic adenocarcinoma Unresectable disease Locally advanced or metastatic disease Clinically or radiologically documented disease Measurable or evaluable disease (phase I) Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan (phase II) Measurable lesion must be outside of previously irradiated field if it is the sole site of disease unless there is documented disease progression No known brain metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy More than 12 weeks Hematopoietic Platelet count ≥ 100,000/mm^3 Absolute granulocyte count ≥ 1,500/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if clearly attributable to liver metastasis) Renal Creatinine normal Cardiovascular No active cardiomyopathy No congestive heart failure No unstable angina pectoris No cardiac arrhythmia No uncontrolled hypertension No myocardial infarction within the past 12 months Pulmonary No pulmonary disease requiring oxygen supplementation Gastrointestinal Must not require IV hyperalimentation No uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn's disease or ulcerative colitis) No active peptic ulcer disease No postsurgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency No other GI tract disease resulting in an inability to take oral medications Must be able to take oral medication without crushing, dissolving, or chewing tablets Pancreatic enzyme supplementation allowed provided the above conditions are met Immunologic No immune deficiency No active, uncontrolled, or serious infection No know hypersensitivity to study drugs or their components No known HIV positivity Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of psychiatric illness (e.g., uncontrolled psychotic disorders) or neurologic disorder that would preclude study compliance No other serious medical condition or illness that would preclude study participation No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix or bladder PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine given concurrently with radiotherapy as a radiosensitizer At least 4 weeks since prior fluorouracil or gemcitabine Endocrine therapy Concurrent systemic hormonal therapy for symptom control (e.g., appetite stimulation, pain, or nausea) allowed Radiotherapy See Disease Characteristics See Chemotherapy At least 4 weeks since prior radiotherapy for local disease and recovered Surgery At least 3 weeks since prior major surgery Other At least 2 weeks since prior anticancer therapy or investigational agents The following drugs must not be used for 1-2 weeks before, during, and for 1-2 weeks after completion of study treatment: Ketoconazole Itraconazole Ritonavir Mibefradil Clarithromycin Saquinavir mesylate Indinavir sulfate Erythromycin Nefazodone hydrochloride Fluconazole Diltiazem hydrochloride Alfentanil hydrochloride Carbamazepine Cyclosporine Tacrolimus Lovastatin Simvastatin Any other drug known to be a potent inhibitor of cytochrome 3A4 No other concurrent anticancer therapy or investigational agents
Sites / Locations
- BCCA - Vancouver Cancer Centre
- Ottawa Health Research Institute - General Division
- Algoma District Cancer Program
- Univ. Health Network-Princess Margaret Hospital
Arms of the Study
Arm 1
Experimental
AZD0530 + Gemcitabine