Clinical trial NCT00066781 (phase 2, status: completed)
Conditions: carcinoma of unknown primary
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: gemcitabine hydrochloride, irinotecan hydrochloride
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12
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