A Phase I/2 Study of GTI-2040 Combined With Docetaxel In Metastatic Or Unresectable Locally Advanced Non-Small Cell Lung Cancer

Date de début de l'étude : 1 octobre 2003

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