Clinical trial NCT00072215 (phase 3, status: terminated)
Conditions: extragonadal germ cell tumor, testicular germ cell tumor
ICD codes: E29.0, E29.1, E29.8, E29.9, E89.5, N50.811, N50.812
Drugs: cisplatin, ifosfamide, paclitaxel, vinblastine
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed germ cell tumor (GCT), including 1 of the following primary
             tumor sites:

               -  Seminoma

                    -  Testis

                    -  Retroperitoneum

                    -  Mediastinum

                    -  Other extragonadal site

               -  Nonseminoma

                    -  Testis

                    -  Retroperitoneum

                    -  Other extragonadal site

                         -  No tumor of the mediastinum

          -  Must have evidence of metastatic disease, including either of the following:

               -  Unidimensionally measurable lesions

                    -  At least 20 mm by conventional techniques (e.g., physical exam for
                       clinically palpable lymph nodes and superficial skin lesions or chest x-ray
                       for clearly defined lung lesions surrounded by aerated lung) OR at least 10
                       mm by spiral CT scan or MRI

               -  Nonmeasurable lesions, including the following:

                    -  Small lesions

                    -  Bone lesions

                    -  Pleural or pericardial effusions

                    -  Ascites

                    -  Irradiated lesions, unless progression is documented after radiotherapy

          -  Progressive or recurrent disease meeting at least 1 of the following criteria:

               -  Measurable progressive disease

               -  Biopsy-proven residual disease

               -  Persistently elevated or rising ß-human chorionic gonadotropin (HCG) or
                  alpha-fetoprotein (AFP) titers with no other clear cause for elevation

          -  Previously treated with 1 and only 1 regimen comprising etoposide and cisplatin with
             or without bleomycin AND exhibits clinical resistance by at least 1 of the following
             conditions after therapy*:

               -  Progressive GCT after a partial response to first-line therapy

               -  Relapse after complete response (CR) to first-line therapy, including partial
                  response (PR) surgically converted to CR

               -  Second testicular primary with evidence of metastases after first-line therapy

               -  Relapse after adjuvant chemotherapy NOTE: *Patients failing to achieve PR or CR
                  with first-line therapy as evidenced by rising markers or new disease within 4
                  weeks of first-line therapy are not eligible

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL (transfusion allowed)

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal* (ULN)

          -  AST and ALT ≤ 2.5 times ULN* NOTE: *Unless hepatic metastases are present

        Renal

          -  Creatinine ≤ 1.5 times ULN OR

          -  Creatinine clearance ≥ 50 mL/min

        Other

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior dose-intensive therapy with stem cell replacement

        Chemotherapy

          -  See Disease Characteristics

          -  At least 3 weeks since prior chemotherapy

          -  No prior paclitaxel

          -  No prior docetaxel

          -  No prior ifosfamide

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  At least 3 weeks since prior radiotherapy

          -  Concurrent or sequential radiotherapy to brain metastases allowed

          -  No other concurrent palliative radiotherapy

        Surgery

          -  See Disease Characteristics

          -  Concurrent surgery for brain metastases allowed

        Other

          -  Recovered from prior therapy