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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Augmerosen in Treating Patients With Untreated Extensive-Stage Small Cell Lung Cancer  Combination Chemotherapy Plus Augmerosen in Treating Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Combination Chemotherapy Plus Augmerosen in Treating Patients With Untreated Extensive-Stage Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Augmerosen may make tumor cells more sensitive to chemotherapy drugs. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and augmerosen in treating patients who have extensive-stage small cell lung cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of augmerosen when combined with standard dose carboplatin and etoposide in patients with untreated extensive stage small cell lung cancer. - Determine the toxicity and feasibility of this regimen in these patients. - Determine potential antitumor activity of this regimen as assessed by objective response in these patients. OUTLINE: This is a dose-escalation, multicenter study of augmerosen (G3139). Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 6-12 patients will be accrued for this study within 5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed extensive stage small cell lung cancer - No prior anticancer therapy except CNS radiotherapy - No active CNS disease - CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 - Karnofsky 60-100% Life expectancy: - More than 2 months Hematopoietic: - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal (ULN) - PT and PTT no greater than 1.5 times ULN Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to compounds of similar chemical or biologic composition to study agents - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 1 week since prior CNS radiotherapy and recovered - No prior radiotherapy to more than 25% of skeleton Surgery: - Not specified Other: - No other concurrent investigational agents - No other concurrent anticancer therapy - No concurrent anticoagulation therapy - No concurrent combination anti-retroviral therapy for HIV
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesRudin, Study Chair, University of Chicago Cancer Research Center
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085
United States
Loyola University Medical Center
Maywood, Illinois, 60153-5589
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: CDR0000068667; NCI-5110,UCCRC-10992A
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017251
Other Extensive Stage Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer.
2. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
3. Combination Chemotherapy and Imatinib Mesylate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
5. Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Related Studies:
Other extensive stage small cell lung cancer Clinical Trials
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Combination Chemotherapy Plus Augmerosen in Treating Patients With Untreated Extensive-Stage Small Cell Lung Cancer
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