GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors
Recurrent Non-small Cell Lung Cancer, Recurrent Prostate Cancer, Stage III Prostate Cancer
About this trial
This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer
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
Sites / Locations
- Princess Margaret Hospital Phase 2 Consortium
Arms of the Study
Arm 1
Experimental
Treatment (GTI-2040, docetaxel)
Phase I (closed to accrual as of 8/5/2004): Patients receive GTI-2040 IV continuously on days 1-14. Patients also receive docetaxel IV over 1 hour on day 3 during course 1 and on day 1 for all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of GTI-2040 and docetaxel until the MTD is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The RP2D is defined as the dose preceding the MTD. Phase II: Patients receive GTI-2040 and docetaxel at the RP2D as in phase I.