Clinical trial NCT00423293 (phase 2, status: completed)
Conditions: anal cancer
ICD codes: C21.1, C44.500, C44.590, D12.9, C21.8
Drugs: fluorouracil, mitomycin c
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CO[C@]12[C@H]3N[C@H]3CN1C1=C([C@H]2COC(N)=O)C(=O)C(N)=C(C)C1=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed carcinoma of the anal canal, including any of the following
             subtypes:

               -  Squamous cell

               -  Basaloid

               -  Cloacogenic

          -  Primary invasive disease

          -  T2-4, N0-3 disease

               -  Clinically positive small inguinal nodes (i.e., < 1 cm in size) must be confirmed
                  by biopsy (preferably fine-needle aspiration) within the past 6 weeks

               -  Biopsy is not required for enlarged inguinal, perirectal, or pelvic nodes on exam
                  or CT scan that are found to be ≥ 1.0 cm and are considered to be clinically
                  positive

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

          -  ALT and AST < 3 times upper limit of normal

          -  Absolute neutrophil count ≥ 1,800/mm³

          -  Serum creatinine ≤ 1.5 mg/dL

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin < 1.4 mg/dL

          -  WBC ≥ 3,000/mm³

          -  INR ≤ 1.5

          -  No known AIDS

               -  HIV-positive patients without AIDS are eligible

               -  HIV test required for patients with clinical suspicion of AIDS

          -  No other invasive malignancy within the past 3 years except for nonmelanomatous skin
             cancer

          -  No severe, active comorbidity, defined as any of the following:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the past 6 months

               -  Transmural myocardial infarction within the past 6 months

               -  Acute bacterial or fungal infection requiring IV antibiotics

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study treatment

               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

               -  Uncontrolled diabetes mellitus, uncompensated heart disease, and/or uncontrolled
                  high blood pressure, that in the opinion of the patient's treating physician,
                  requires an immediate change in management

                    -  Patients may be eligible if appropriate changes in management have resulted
                       in adequate control of the above mentioned conditions

               -  Other immunocompromised status (e.g., organ transplantation or chronic
                  glucocorticoid use)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior radiation therapy to the pelvis that would result in overlap of radiation
             therapy fields

          -  No prior systemic chemotherapy for cancer of the anus

          -  No prior surgery for cancer of the anus that removed all macroscopic anal cancer

          -  No concurrent sargramostim (GM-CSF)

          -  No concurrent amifostine