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A Trial of Maintenance ADAPT Therapy With Capecitabine and Celecoxib in Patients With Metastatic Colorectal Cancer

Complete title: A Phase II Trial of Maintenance ADAPT Therapy with Capecitabine and Celecoxib in Patients with Metastatic Colorectal Cancer

Research Study Number       7707
Principal Investigator       Edward Lin, MD
Phase       II

Look up trial at NIH

Research Study Description

This phase II trial studies how well capecitabine and celecoxib with or without radiation therapy works in treating patients with colorectal cancer that is newly diagnosed or has been previously treated with fluorouracil, and has spread to other parts of the body (metastatic). 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving capecitabine and celecoxib together with radiation therapy may kill more tumor cells.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Histologically confirmed colorectal cancer

- Evaluable or measurable radiographic evidence of colorectal cancer

- Patients with unresected metastases from colorectal cancer; patients may be either untreated with chemotherapy or currently receiving first-line 5-FU based chemotherapy (folinic acid-fluorouracil-irinotecan hydrochloride [FOLFIRI], capecitabine-irinotecan hydrochloride [CAPIRI], fluorouracil-leucovorin calcium-oxaliplatin [FOLFOX], or capecitabine-oxaliplatin [CAPOX] with or without bevacizumab) within 10 months of beginning ADAPT therapy with at least stable disease radiographically; patients who received prior adjuvant chemotherapy with 5-FU, capecitabine, or FOLFOX are eligible if adjuvant therapy was completed greater than 6 months ago

- History of histological confirmation for recurrent disease, or if recurrent disease is not readily accessible to biopsy, must have two consecutive carcinoembryonic antigen (CEA) or cancer antigen (CA) 19-9 increases, or positron emission tomography (PET) avidity

- Men and women from all ethnic and racial groups

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Total bilirubin =< 1.5 x the institutional upper-normal limit (IUNL)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and/or alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x IUNL

- Alkaline phosphatase =< 2.5 x IUNL

- Leukocytes >= 3,000/uL

- Absolute neutrophil count >= 1,000/uL

- Platelets >= 100,000/uL

- Women of childbearing potential and all men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to beginning ADAPT therapy and for the duration of study participation

- Negative urine pregnancy test for women of childbearing potential

- Must have the ability to understand and the willingness to provide a written informed consent to participate in the study

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- History of allergies to sulfonamide, aspirin, any nonsteroidal anti-inflammatory drugs (NSAIDS), 5-FU or celecoxib

- Prior 5-FU-based adjuvant chemotherapy less than 6 months prior to beginning ADAPT therapy and any residual neuropathy > grade 2

- Any regular use of cyclooxygenase-2 (COX-2) inhibitors as defined by 2-3 times per week

- Use of aspirin is NOT an exclusion criterion as long as the daily dose does not exceed 325 mg daily; initiation of ADAPT therapy requires patient to discontinue aspirin for 18 months

- Pregnant or lactating women

- History of significant neurologic or psychiatric disorders, including dementia or seizures that would impede consent, treatment, or follow up

- Any serious illness or medical condition that could affect participation on trial

- Any uncontrolled congestive heart failure New York Heart Association class III or IV

- Any uncontrolled hypertension, arrhythmia, or active angina pectoris

- Any history of major myocardial infarction, stroke or transient ischemic attack (TIA); minor acute myocardial infarction (AMI) and patients who have had cardiac bypass free of symptoms for at least 2 years may be eligible at the discretion of the study chair

- Serious uncontrolled active infection

- Patients with creatinine clearance: < 50 mL/min are excluded from this protocol; capecitabine is contraindicated in severe renal impairment (clearance < 40 mL/min)

- Inability to swallow oral medications or any medical conditions that may affect intestinal absorption of the study agent or inability to comply with oral medication

- History of active peptic ulcer disease or major upper gastrointestinal (GI) bleed < 12 months; history of GI bleeding from the colorectal cancer primary is not an exclusion criterion

- Use of warfarin is not allowed; patient is recommended to switch to low molecular weight heparin (LMWH) before participating in this study

- Patients with any history of brain or bone metastasis or who have developed progressive disease on first line 5-FU based therapy

- Current use of systemic steroid medication

- Patients with an obstructive synchronous colorectal tumor requiring up-front surgery or chemoradiation

- Patients with partial or complete bowel obstruction due to abdominal carcinomatosis

Other exclusion criteria may apply.

Research Study Number       7707
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Colon Cancer; Gastrointestinal Cancer; Rectal Cancer; Solid Tumors; Neoplasms; Digestive System Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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