Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
Condition: Carcinoma of Unknown Primary
MeSH terms: Carcinoma; Neoplasms, Unknown Primary
Intervention: gemcitabine hydrochloride; irinotecan hydrochloride
Intervention description: Given IV; Given IV
Intervention MeSH terms: Gemcitabine; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of unknown primary; newly diagnosed carcinoma of unknown primary; squamous cell carcinoma of unknown primary; undifferentiated carcinoma of unknown primary

Summary:

      RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan use different ways
      to stop tumor cells from dividing so they stop growing or die. Combining more than one drug
      may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan
      works in treating patients with cancer of unknown primary origin.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed carcinoma of undetermined origin, with any of the following
             light microscopic diagnoses:

               -  Adenocarcinoma

                    -  Poorly differentiated non-small cell carcinoma

                    -  Poorly differentiated squamous cell carcinoma

          -  Primary site not revealed by the following diagnostic tests:

               -  Complete history and physical

               -  Complete blood count and chemistries

               -  Chest x-ray and/or CT scan

               -  Abdominal CT scan

               -  Directed evaluation of symptomatic areas

               -  Mammogram in women

               -  Colonoscopy in patients with liver metastases to exclude a colon primary

               -  Hematoxylin and eosin (H&E) staining OR immunostaining if H&E results are
                  unclear, including all of the following:

                    -  Keratin or epithelial membrane antigen

                    -  S-100 or HMB45

                    -  LCA (CD45)

                    -  Chromogranin or synaptophysin

                    -  Thyroid transcription factor 1

          -  Measurable disease

          -  Patients with any of the following conditions are not eligible:

               -  Neuroendocrine tumors

               -  Women with axillary node involvement only

               -  Women with adenocarcinoma of the peritoneum

               -  Carcinoma involving only 1 site, with resectable tumor at that site

               -  Squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph
                  nodes

               -  Men with poorly differentiated mediastinal or retroperitoneal tumor with stains
                  suggestive of germ cell origin or serum tumor markers (AFP/HCG)

               -  Men with prominent blastic bony metastases or markedly elevated prostate-specific
                  antigen, suggesting prostate origin

          -  Must be willing to provide blood and tissue samples

          -  No brain or meningeal involvement

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin must meet 1 of the following criteria:

               -  Less than or equal to upper limit of normal (ULN) and no UGT1A1 genotyping is
                  required

               -  Greater than ULN but less than 2 times ULN and UGT1A1 for 6/7 genotype or 7/7
                  genotype patients

          -  Alkaline phosphatase no greater than 3 times ULN

          -  AST no greater than 3 times ULN (5 times ULN if liver metastases are present)

        Renal

          -  Creatinine no greater than 2.0 times ULN

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other invasive malignancy within the past 5 years

          -  No other severe concurrent disease that would make the patient inappropriate for the
             study in the judgment of the investigator

          -  No uncontrolled infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent biologic agents

          -  No concurrent filgrastim (G-CSF)

        Chemotherapy

          -  No prior chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy to more than 25% of the bone marrow

          -  No concurrent radiotherapy

        Surgery

          -  More than 4 weeks since prior major surgery