Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well capecitabine works as second-line therapy in treating patients with stage IV pancreatic cancer who have the thymidylate synthase gene.

• 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: Capecitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed pancreatic cancer

• Stage IV disease

• Measurable disease (≥ 1 cm or > 10 mm lesion(s) by spiral CT scan)

• Disease progression after ≥ 1 gemcitabine-based treatment regimen for advanced/metastatic disease

• Patient carries the double tandem repeat (S/S) variant of the thymidylate synthase gene enhancer region (TSER)

• No active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• AST/ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if attributable to liver metastases)

• Total bilirubin ≤ 1.5 times ULN

• Creatinine normal OR creatinine clearance > 50 mL/min

• Fertile patients must use effective contraception during and for 30 days after completion of study treatment

• Not pregnant or nursing

• Negative pregnancy test

• Asymptomatic HIV infection allowed

• No recent or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, bleeding, inflammation, emesis, or diarrhea > grade 1)

• Able to swallow capecitabine tablets

• No known hypersensitivity to fluorouracil

• No dihydropyrimidine dehydrogenase (DPD) deficiency

• No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication)

• No myocardial infarction within the past 6 months

• No serious, uncontrolled, concurrent infection(s)

• No prior unanticipated severe reaction to fluoropyrimidine therapy

• No other malignancy within the past 5 years except cured nonmelanoma skin cancer or treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy

• No prior capecitabine except in the adjuvant setting

• At least 3 weeks since prior radiotherapy or major surgery

• At least 4 weeks since prior participation in any investigational drug study

• At least 4 weeks since prior sorivudine or brivudine

• No concurrent sorivudine or brivudine

• No concurrent cimetidine or azidothymidine (AZT)

• Concurrent radiotherapy for bone pain allowed to a limited field provided ≥ 1 indicator lesion remains outside of the field

• No other concurrent chemotherapy or immunotherapy