Clinical trial NCT00074022 (phase 1/phase 2, status: completed)
Conditions: recurrent non-small cell lung cancer, recurrent prostate cancer, stage iii prostate cancer, stage iiia non-small cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer, stage iv prostate cancer, unspecified adult solid tumor, protocol specific
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of 1 of the following:

               -  Solid tumor malignancy (phase I only)*

               -  Prostate cancer (phase I only)*

               -  Non-small cell lung cancer (phase I and II)*

          -  Recurrent, metastatic, locally advanced unresectable, or treatment-refractory disease

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion at least 20 mm by conventional
                  techniques OR at least 10 mm by spiral CT scan

               -  Previously irradiated lesions are considered measurable provided they have
                  demonstrated progression before study entry

               -  No bone-only disease

                    -  Must have measurable disease other than bone lesions

          -  No stage IIIA or IIIB non-small cell lung cancer without a malignant pleural or
             pericardial effusion that is eligible for first-line radical combined chemotherapy and
             radiotherapy

          -  No known progressive or symptomatic brain metastases

               -  Asymptomatic brain metastases allowed

          -  Performance status - ECOG 0-2

          -  Performance status - Karnofsky 60-100%

          -  More than 3 months

          -  WBC at least 3,000/mm^3

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  No history of coagulopathy

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST/ALT no greater than 2 times ULN (3.5 times ULN if liver metastases are present)

          -  INR no greater than 1.3

          -  APTT no greater than 1.25 times ULN

          -  Creatinine no greater than 1.5 times ULN

          -  Creatinine clearance at least 50 mL/min

          -  No symptomatic congestive heart failure

          -  No evidence of cardiac dysfunction

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active peptic ulcer disease

          -  No poorly controlled diabetes mellitus

          -  No pre-existing grade 2 or greater neuropathy

          -  No ongoing or active infection

          -  No contraindication to corticosteroids

          -  No psychiatric illness or social situation that would limit compliance with study
             requirements

          -  No prior allergic reaction attributed to compounds of similar chemical or biological
             composition to study drugs

          -  No other concurrent uncontrolled illness

          -  One, and only one, prior chemotherapy regimen for advanced disease (not including
             adjuvant therapy) allowed

               -  Neoadjuvant/adjuvant chemotherapy allowed

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin)
             and recovered

          -  Prior multiple lines of endocrine therapy for advanced solid tumors allowed

          -  More than 4 weeks since prior endocrine therapy and recovered

          -  Concurrent steroids allowed

          -  See Disease Characteristics

          -  More than 4 weeks since prior radiotherapy and recovered

          -  No concurrent radiotherapy to sole site of measurable disease

          -  Prior surgery allowed

          -  No concurrent anticoagulant therapy

               -  Concurrent low-dose warfarin for central line thrombosis prophylaxis allowed

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational or commercial agents or therapies intended to
             treat the malignancy

          -  Concurrent bisphosphonates allowed