NCT00303927

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 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2 pancreatic-cancer

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

March 19, 2010

Status Verified

March 1, 2010

Enrollment Period

1.8 years

First QC Date

March 15, 2006

Last Update Submit

March 18, 2010

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (2)

  • Survival at 6-months

  • Toxicity

Secondary Outcomes (3)

  • Association between capecitabine exposure at steady-state, allelic variants in candidate genes, and drug response

  • Relationship between expression of TS, TP and DPD in tumor tissues and response

  • Response rate

Interventions

capecitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Wells Messersmith, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 17, 2006

Study Start

December 1, 2005

Primary Completion

September 1, 2007

Last Updated

March 19, 2010

Record last verified: 2010-03

Locations

US(1)ES(1)