Status:
COMPLETED
Capecitabine as Second-Line Therapy in Treating Patients With Stage IV Pancreatic Cancer Who Have the Thymidylate Synthase Gene
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pha...
Detailed Description
OBJECTIVES: Primary * Characterize the 6-month survival of patients with stage IV pancreatic cancer (progressing after at least 1 prior gemcitabine-containing chemotherapy regimen) who carry the dou...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00303927
Start Date
December 1 2005
Last Update
March 19 2010
Active Locations (2)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
2
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041