Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III … (NCT00093379) | Clinical Trial Compass
CompletedPhase 2
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
United States20 participantsStarted 2004-04
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Previously untreated patients with histologically proven squamous cell carcinoma of the anal canal.
✓. American Joint Committee on Cancer (AJCC) stage II-IIIB (TX 1-4, NX, MO).
✓. Age \>/= 16 yrs old.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-1.
✓. Adequate organ function including: Absolute neutrophil Count (ANC) \>/= 1,500/uL, Platelets \>/= 100,000/uL, Total bilirubin \</= 1.5 \* upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 3 \* ULN, Creatinine \</= 1.5mg/dL or Creatinine Clearance (CrCL) \>/= 50 cc/min.
✓. Patients may have measurable or non-measurable disease. Patients with measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, have at least one lesion that can be accurately measured in at least one dimension with longest diameter to be recorded \>/= 20 mm using conventional techniques or \>/= 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). Lesions seen on colonoscopy or barium studies are not considered measurable lesions.
✓. A negative pregnancy test in all women of child-bearing potential, within two weeks of initiating treatment.
. The effects of oxaliplatin and capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because cytotoxic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion criteria
✕. Prior chemotherapy with oxaliplatin, capecitabine, or 5-fluorouracil.
✕. Prior radiation to the pelvis.
✕. Prior surgery for anal cancer excluding prior biopsy.
✕. Known history of dihydropyrimidine (DPD) deficiency.
✕. Known history of hypersensitivity to platinum-containing compounds.
✕. Peripheral neuropathy of \>/= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) 3.0.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.