Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Intervention: capecitabine; celecoxib; pharmacological study; laboratory biomarker analysis; pharmacogenomic studies
Intervention description: Given PO; Given PO; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Celecoxib; Capecitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial studies capecitabine and celecoxib in treating patients with solid
      malignancies that are metastatic or cannot be removed by surgery. 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. Celecoxib may stop the growth of tumor
      cells by blocking some of the enzymes needed for cell growth. Giving capecitabine and
      celecoxib together may be an effective treatment for solid malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed solid tumor that is metastatic or
             unresectable and for which standard curative or palliative measures do not exist or
             are no longer effective

        OR

        Histologically or cytologically confirmed solid tumor for which single agent capecitabine
        is an appropriate treatment option.

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1

          -  Life expectancy > 3 months

          -  Absolute neutrophil count (ANC) >= l500/ul

          -  Hemoglobin >= 9g/dL

          -  Platelets >= 100,000/ul

          -  Creatinine within institutional normal limits or glomerular filtration rate >= 50
             mL/min/1.73 m^2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI)
             equation

          -  Total bilirubin < 1.5 x upper limit of normal

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate
             transaminase (SGPT) < 2.5 x upper limit of normal for patients without liver
             metastases OR SGOT and SGPT < 5 x upper limit of normal for patients with liver
             metastases

          -  Measurable or non-measurable disease will be allowed

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation, up until 30 days after final study treatment;
             should a woman become pregnant or suspect that she is pregnant while participating in
             this study, she should inform her treating physician immediately

          -  Patients taking substrates of CYP2C9 should be encouraged to switch to alternative
             drugs whenever possible, given the potential for drug-drug interactions with the study
             drugs

          -  Signed informed consent

        Exclusion Criteria:

          -  Prior treatment with capecitabine and/or celecoxib is allowed; however, patients with
             a documented history (at the time of enrollment) of >= grade 3 toxicities with
             capecitabine or celecoxib are excluded

          -  Patients taking any of the following drugs are excluded: inducers or inhibitors of
             CYP2C9, warfarin, aspirin, corticosteroids, or non-steroidal anti-inflammatory drugs
             (NSAIDs)

          -  History of myocardial infarction or stroke within the last 6 months, or history of
             uncontrolled cardiovascular or cerebrovascular disease; a 12-lead electrocardiogram
             (ECG) will be performed during the screening period

          -  History of perforation or bleeding related to peptic ulcer disease

          -  History of hypersensitivity or allergy to study drugs, aspirin, sulfonamides, or
             NSAIDs

          -  Known poor metabolizers of CYP2C9 substrates

          -  Known deficiency of dihydropyrimidine dehydrogenase (DPD)

          -  Patients who have had chemotherapy, immunotherapy, or investigational anti-cancer
             therapy within 4 weeks of starting study drug, or radiotherapy within 14 days of
             starting study drug, or those who have not recovered from adverse events due to agents
             administered more than 4 weeks earlier

          -  Patients may not be receiving any other investigational agents or any concomitant
             antineoplastic therapy, with the exception of androgen ablating agents (for patients
             with prior prostate cancer)

          -  Serious underlying medical or psychiatric illnesses that would, in the opinion of the
             treating physician, substantially increase the risk for complications related to
             treatment; similarly, any unstable medical condition that in the opinion of the
             treating physician or study investigators, would interfere with determination of the
             study objectives

          -  Pregnancy or breastfeeding

          -  Major surgery within 4 weeks