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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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, prostate cancer, or other solid tumors. GTI-2040 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. Combining GTI-2040 with docetaxel may kill more tumor cells

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Docetaxel

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