Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Recurrent Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating patients who have recurrent, metastatic, or unresectable locally advanced non-small cell lung cancer, prost...
Detailed Description
OBJECTIVES: I. Determine the recommended phase II dose of GTI-2040 and docetaxel in patients with recurrent, metastatic, or unresectable locally advanced non-small cell lung cancer, prostate cancer, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00074022
Start Date
October 1 2003
Last Update
January 24 2013
Active Locations (1)
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1
Princess Margaret Hospital Phase 2 Consortium
Toronto, Ontario, Canada, M5G 2M9