Overview

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

Status:
Terminated
Trial end date:
2016-09-06
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Collaborator:
National Cancer Institute (NCI)
Treatments:
Benzenesulfonamide
Capecitabine
Celecoxib
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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