Clinical trial NCT00119314 (phase 2, status: withdrawn)
Conditions: carcinoma of unknown primary
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: capecitabine, docetaxel, gemcitabine hydrochloride
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed malignancy for which no primary origin has
             been identified despite routine workup, including the following:

               -  History and physical examination

               -  Chemistry profile and other blood work, including tumor markers with follow up on
                  any positive findings

               -  CT scan or MRI of the chest, abdomen, and pelvis

               -  Mammography (for female patients)

               -  Prostate examination (for male patients)

               -  Stool guaiac

          -  Measurable disease

               -  Previously irradiated lesions are not considered measurable disease unless there
                  is documented clear tumor progression in these lesions after completion of
                  radiotherapy

          -  The following tumor types or presentations are excluded:

               -  Resectable disease

               -  Tumors consistent with germ cell primary, as indicated by any of the following:

                    -  Midline tumor

                    -  Elevated beta human chorionic gonadotropin

                    -  Elevated alpha-fetoprotein

                    -  i12p chromosomal alteration

               -  Prostate primary with elevated prostate-specific antigen

               -  Females with axillary nodes as the primary disease site

               -  Tumors limited to the peritoneal cavity consistent with primary peritoneal
                  carcinoma

               -  Neuroendocrine tumors

               -  Squamous cell carcinoma involving cervical or inguinal lymph nodes

          -  No symptomatic brain metastases

               -  Prior brain metastases allowed provided patient completed definitive treatment
                  with brain irradiation with or without resection

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  Hemoglobin ≥ 9.0 g/dL

          -  Granulocyte count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

        Hepatic

          -  Bilirubin normal

          -  Meets 1 of the following criteria:

               -  Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit normal
                  (ULN)

               -  AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN

               -  AP ≤ 5 times ULN AND AST and ALT normal

          -  Albumin ≥ 3.0 g/dL

        Renal

          -  Creatinine ≤ 1.5 mg/dL

        Gastrointestinal

          -  Able to take oral medication

          -  Intestinal absorption intact

               -  No uncontrolled diarrhea and/or daily emesis

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception during and for 3 months
             after completion of study treatment

          -  No other malignancy within the past 5 years except curatively treated carcinoma in
             situ of the cervix or basal cell skin cancer

          -  No severe medical or psychiatric illness that would preclude study treatment

          -  No peripheral neuropathy > grade 1

          -  No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for this malignancy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  Recovered from prior radiotherapy

          -  Prior palliative radiotherapy to areas of bony metastases allowed provided there is
             measurable disease outside the radiotherapy port

          -  At least 4 weeks since prior radiotherapy

          -  No prior radiotherapy to ≥ 25% of the bone marrow

        Surgery

          -  See Disease Characteristics

        Other

          -  No concurrent antiviral therapy