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Home > "Z" Clinical Trials Conditions > ZD6474 in Treating Patients With Small Cell Lung Cancer  ZD6474 in Treating Patients With Small Cell Lung Cancer
ZD6474 in Treating Patients With Small Cell Lung Cancer
For Condition: limited stage small cell lung cancer,extensive stage small cell lung cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: ZD6474 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor. PURPOSE: Randomizedphase II trial to study the effectiveness of ZD6474 in treating patients who have small cell lung cancer that has responded to previous chemotherapy with or without radiation therapy.
Details: OBJECTIVES: - Compare the progression-free survival of patients with previously treated small cell lung cancer (SCLC) treated with ZD6474 vs placebo. - Compare the response rate of patients treated with these regimens (only patients who had measurable disease outside a prior radiation field at study entry). - Compare the toxicity and tolerability of these regimens in these patients. - Compare the pharmacokinetics of these regimens in these patients. - Correlate outcome and response with vascular endothelial growth factor expression and microvessel density in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Provide a comprehensive tumor, plasma, and urine bank linked to a clinical database for further study of molecular markers in SCLC. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, timing of prior radiotherapy (early [before day 1, course 4 of chemotherapy] vs late vs no prior radiotherapy), stage of disease at diagnosis (limited vs extensive), and response at study entry (complete vs partial). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral ZD6474 daily. - Arm II: Patients receive oral placebo daily. In both arms, courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 4 weeks while on therapy, and then every 8 weeks until disease progression. Patients are followed every 8 weeks until disease progression and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell carcinoma of the lung - Small cell and variant histology allowed - No mixed tumors (small and large cell) - No neuroendocrine tumors of the lung - Must have received at least 4 courses of first-line combination chemotherapy as part of an induction regimen - No prior change in regimen due to disease progression - Must have achieved a radiologically confirmed (i.e., CT scan, chest x-ray, or bone scan) complete response (CR) or partial response (PR) after prior chemotherapy with or without radiotherapy AND meets 1 of the following criteria: - No more than 28 days since prior chemotherapy - At least 7 and no more than 14 days since prior radiotherapy if administered after completion of prior chemotherapy* - No CNS metastases - Asymptomatic patients with CNS metastases who received prior therapeutic cranial irradiation and are on stable, decreasing, or no steroids are eligible - No symptomatic lesions or evidence of necrosis or bleeding NOTE: *Randomization may take place up to 21 days after prior radiotherapy in the instance of severe esophagitis that precludes administration of oral medications PATIENT CHARACTERISTICS: Age - Over 16 Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No history of bleeding diathesis Hepatic - Bilirubin less than 1.5 times upper limit of normal (ULN) - ALT less than 2.5 times ULN Renal - Creatinine less than 1.5 times ULN - Calcium normal Cardiovascular - No prior ventricular arrhythmia that was symptomatic or required treatment (CTC grade 3), including any of the following: - Multifocal premature ventricular contractions - Bigeminy - Trigeminy - Ventricular tachycardia - No prior QT prolongation with any medication - No congenital long QT syndrome - No QT and QTc (with Bazett's correction) that is unmeasurable or is 460 msec or higher on screening ECG - No significant cardiac event, including symptomatic heart failure or angina, within the past 3 months or any cardiac disease that increases the risk for ventricular arrhythmia - No ongoing chronic atrial fibrillation - LVEF at least 45% by MUGA for patients with significant cardiac history (myocardial infarction, severe hypertension, or arrhythmia) OR who received prior doxorubicin greater than 450 mg/m^2 Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Potassium normal - Magnesium normal - No serious active infection - No recent major bleeding - No other concurrent serious underlying medical condition that would preclude study participation - Willing and able to complete quality of life questionnaires in English or French PRIOR CONCURRENT THERAPY: Biologic therapy - No prior signal transduction inhibitors - No prior angiogenesis inhibitors - No concurrent anticancer biologic therapy or immunotherapy Chemotherapy - See Disease Characteristics - Recovered from prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - Recovered from prior radiotherapy - No concurrent anticancer radiotherapy - Concurrent low-dose, nonmyelosuppressive palliative radiotherapy allowed Surgery - More than 2 weeks since prior major surgery Other - More than 4 weeks since prior investigational drugs - No prior epidermal growth factor receptor inhibitors - No prior vascular endothelial growth factor receptor inhibitors - No concurrent CYP3A4 inhibitors or inducers, including any of the following: - Ketoconazole - Erythromycin - Verapamil - Rifampin - Phenytoin - Carbamazepine - Barbiturates - Hypericum perforatum (St. John’s wort) - No concurrent medication that affects QT/QTc and/or induces torsades de pointes - No other concurrent anticancer cytotoxic therapy - No other concurrent investigational drugs during and for 30 days after study participation - No concurrent oral bisphosphonates (e.g., clodronate) - Concurrent IV bisphosphonates allowed - No concurrent 5HT_3 antagonists
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndrewArnold, Study Chair, Margaret and Charles Juravinski Cancer Centre
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Andrew Arnold 905-387-9495
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Desiree Hao 403-944-1707
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Glenwood Goss 613-737-7700 ext. 56758
Saskatoon Cancer Centre *Recruiting*
Saskatoon, Saskatchewan, S7N 4H4
Canada
Recruiting Amer Sami 306-655-2604
Mount Sinai Hospital - Toronto *Recruiting*
Toronto, Ontario, M5G 1X5
Canada
Recruiting Ronald Burkes 416-586-5117
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Michael Smylie 780-432-8757
British Columbia Cancer Agency - Centre for the Southern Interior *Recruiting*
Kelowna, British Columbia, V1Y 5L3
Canada
Recruiting David Fenton 250-712-3900 ext. 3930
L'Hopital Laval *Recruiting*
Ste Foy, Quebec, G1V 4G5
Canada
Recruiting Francis Laberge 418-656-4747
Hopital Notre- Dame du CHUM *Recruiting*
Montreal, Quebec, H4L 2M1
Canada
Recruiting Joseph Ayoub 514-890-8070
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Richard Gregg 613-544-2630
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Frances Shepherd 416-946-4522
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting Margot Burnell 506-648-6884
Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey, British Columbia, V3V 1Z2
Canada
Recruiting Christopher Lee 604-930-2098
Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines, Ontario, L2R 5K3
Canada
Recruiting Brian Findlay 905-682-6451
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Yee Ung 416-480-4951
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Barbara Melosky 604-877-6098 ext. 2017
Toronto East General Hospital *Recruiting*
Toronto, Ontario, M4C 3E7
Canada
Recruiting Jacinta Meharchand 416-469-3325
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Adrien Chan 807-684-7200
Cancer Care Ontario - Windsor Regional Cancer Centre *Recruiting*
Windsor, Ontario, N8W 2X3
Canada
Recruiting Yasmin Alam 519-523-3191 ext. 58504
Additional Information:
Study ID Numbers: CDR0000315518; ZENECA-6474IL/0005,CAN-NCIC-BR20
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066313
Other Extensive Stage Small Cell Lung Cancer Studies:
1. Imatinib Mesylate and Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
2. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer
3. Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer
5. Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Related Studies:
Other extensive stage small cell lung cancer Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
ZD6474 in Treating Patients With Small Cell Lung Cancer
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