Sirolimus in Treating Patients With Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with advanced pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically proven adenocarcinoma of the pancreas

• Locally-advanced or advanced disease which has progressed after one prior gemcitabine-containing regimen

• Unidimensionally measurable disease (defined as at least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan) OR evaluable disease

• Tumor tissue available for IHC assessment OR willingness to undergo a safe biopsy of tumor tissue

Exclusion criteria:

• Histologic or cytologic diagnosis that is not consistent with adenocarcinoma, including adenosquamous, islet cell, cystadenoma or cystadenocarcinoma, carcinoid, or small or large cell carcinoma or lymphoma

• Adenocarcinoma arising from a site other than the pancreas (e.g., distal common bile duct, ampulla of vater or periampullary duodenum)

• Known brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-1

• WBC > 3,500 cells/mm³

• ANC > 1,500 cells/mm³

• Hemoglobin > 9 g/dL

• Serum creatinine ≤ 2.0 mg/dL

• Bilirubin ≤ 2 mg/dL

• ALT, AST, and alkaline phosphatase ≤ 5 times upper limit of normal

• Triglycerides and total cholesterol < 2 times upper limit of normal

• Not pregnant or nursing

Exclusion criteria:

• Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy, including immunodeficiency and chronic treatment with immunosuppressors

• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease

• Active infections

• History of concurrent malignancy or history of a second malignancy within the past 5 years

• Clinically significant cardiovascular disease, including myocardial infarction (within 12 months prior to randomization), unstable angina, grade II or greater peripheral vascular disease, uncontrolled congestive heart failure, or uncontrolled hypertension (i.e., systolic blood pressure (BP) > 170 mm Hg, diastolic BP > 95 mm Hg)

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

• Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy

• Any previous surgery, excluding minor procedures (e.g., dental work or skin biopsy) within 4 weeks of enrollment

• Participation in an investigational new drug trial within 1 month of starting trial

• Treatment with chemotherapy within 30 days of day 1 treatment

• At least 10 days since prior and no concurrent:

• Cyclosporine

• Diltiazem

• Ketoconazole

• Rifampin

• St. Johns wort

• Grapefruit juice

• Concurrent phenytoin, carbamazepine, barbiturates, or phenobarbital

• No other concurrent investigational or commercial agents