Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Intervention: gemcitabine hydrochloride; oxaliplatin
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the colon; recurrent colon cancer; stage IV colon cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with
      oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent
      colon cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the colon

               -  Metastatic or recurrent disease

               -  Redocumentation of tumor histology or cytology prior to protocol therapy is not
                  required if documented tumor was confirmed prior to initial therapy

          -  Measurable disease

               -  Lesion of ≥ 1 cm in longest diameter that can be repetitively assessed by
                  radiographic measurement or any lesion of ≥ 2 cm in longest diameter that can be
                  repetitively assessed by physical examination

               -  Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions,
                  and positive bone marrow biopsies are not considered measurable or evaluable
                  lesions

          -  Metastatic disease to the brain allowed if emergent radiotherapy for symptomatic CNS
             disease is not required

          -  Must have received at least one prior chemotherapy regimen (with or without
             radiotherapy)

               -  One of the prior regimens must include irinotecan hydrochloride, fluorouracil,
                  and leucovorin calcium or irinotecan hydrochloride and other fluoropyrimidine

               -  Previous therapy with C-225 and/or bevacizumab is allowed

          -  .

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Granulocyte count ≥1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine ≤ 2.0 mg/dL

          -  Bilirubin < 1.5 mg/dL

          -  SGOT ≤ 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase < 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No serious medical or psychiatric illness that would render chemotherapy unsafe

          -  No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer,
             low-grade low-stage bladder carcinoma followed off therapy, or lobular neoplasia of
             the breast

          -  No clinical AIDS or known positive HIV serology

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior therapy

          -  No investigational agent for at least 30 days prior to study entry

          -  No chemotherapy within the past 3 weeks

          -  No radiotherapy for palliation within the past 2 weeks prior to study entry

          -  No prior oxaliplatin or gemcitabine hydrochloride

          -  No concurrent participation in another clinical trial

          -  No other concurrent anticancer therapy including chemotherapy, radiotherapy, hormonal
             therapy, or immunotherapy

          -  No other concurrent investigational drugs