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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 Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Subjects typically recieve the finest healthcare available for their 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 condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > 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  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
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
For Condition: adult solid tumor,Non-small cell lung cancer,Prostate Cancer
Status: Recruiting
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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 PURPOSE: Phase I/II trial to study the effectiveness of combining GTI-2040 with docetaxel in treating patients who have recurrent, metastatic, or unresectablelocally advancednon-small cell lung cancer, prostate cancer, or other solid tumors.
Details: OBJECTIVES: - 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, or other solid tumors. - Determine the toxicity of this regimen in these patients. - Determine the objective tumor response rate in patients treated with this regimen. - Determine the stable disease rate, time to disease progression, objective response duration, and duration of stable disease in patients treated with this regimen. - Determine the pharmacokinetics of GTI-2040 when administered in combination with docetaxel in these patients. - Correlate the pharmacokinetics of GTI-2040 with the biological and toxic effects of this regimen in these patients. - Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc, ras, pRAF1, pMAPK, and markers of apoptosis with clinical outcome in patients treated with this regimen. OUTLINE: This is an open-label, dose-escalation, multicenter study. - 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 maximum tolerated dose (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 recommended phase II dose (RP2D) is defined as the dose preceding the MTD. - Phase II: Patients receive GTI-2040 and docetaxel at the RP2D as in phase I. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12-48 patients (12-18 for phase I and 15-30 for phase II) will be accrued for this study within 4-16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - 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 Hepatic - 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 Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 50 mL/min Cardiovascular - No symptomatic congestive heart failure - No evidence of cardiac dysfunction - No unstable angina pectoris - No cardiac arrhythmia Other - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - 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 Endocrine therapy - Prior multiple lines of endocrine therapy for advanced solid tumors allowed - More than 4 weeks since prior endocrine therapy and recovered - Concurrent steroids allowed Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy to sole site of measurable disease Surgery - Prior surgery allowed Other - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NatashaLeighl, Study Chair, Princess Margaret Hospital
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Natasha Leighl 416-946-2399
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Scott Laurie 613-737-7700 ext. 56809
Additional Information:
Study ID Numbers: CDR0000341677; NCI-6104,PMH-PHL-017
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074022
Other Adult Solid Tumor Studies:
1. Evaluation of efficacy, safety and tolerability of Targretin capsules in patients with advanced or metastatic non-small cell lung cancer
2. TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer
3. INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
4. Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
5. Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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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
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