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Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer
Conditions
Small Cell Lung Carcinoma
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Conditions: Keywords
Irinotecan; Cisplatin; Small-cell lung cancer; UGT1A1
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Irinotecan
Type: Drug
Name: Cisplatin
Type: Drug
Overall Status
Recruiting
Summary
As the gene polymorphism of uridine diphosphate glucuronosyl transferase 1A1(UGT1A1)is related to the side effect of diarrhea induced by irinotecan. UGT1A1 gene *28 (6/6 and 6/7) and *6 (G/G and G/A) is related to low probability of diarrhea and UGT1A1 gene *28 (7/7) and *6 (A/A)is related to high probability of diarrhea. The purpose of this study is to find out the efficacy and side effect between two different dosages of irinotecan combined with cisplatin scheme in extensive disease-small cell lung cancer with UGT1A1 gene *28 (6/6 and 6/7)and *6 (G/G and G/A), based on the hypothesis that the UGT1A1 gene *28 (7/7) and *6 (A/A)is few in the Chinese population and increasing the dose of irinotecan can improve the efficacy without increasing the side effect in the patients with UGT1A1 gene *28 (6/6 and 6/7)*6 (G/G and G/A).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Histologic or cytologic diagnosis of small-cell lung cancer
- Extensive-stage disease, defined as disease extending beyond one hemithorax involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or pleural effusion.
- Males or females between 18 to 75 years
- No prior chemotherapy, if the surgery or radiotherapy has been administered, the interval is at least above four weeks.
- Performance status of 0-2 on the ECOG criteria. Expected survival is above three months.
- At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
- Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNL x 1.5), and renal (creatinine =< UNL) function
- The gene type of UGT1A1 *28 is 6/6 and 6/7.
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
- No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.
Exclusion Criteria:
- Non small cell lung cancer and carcinoid
- Medically uncontrolled severe diarrhea in recent three weeks.
- Inability to comply with protocol or study procedures.
- Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Pregnant or breast-feeding.
- Enrollment in other study within 30 days
- Brain metastasis with symptoms
- Histologic or cytologic diagnosis of small-cell lung cancer
- Extensive-stage disease, defined as disease extending beyond one hemithorax involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or pleural effusion.
- Males or females between 18 to 75 years
- No prior chemotherapy, if the surgery or radiotherapy has been administered, the interval is at least above four weeks.
- Performance status of 0-2 on the ECOG criteria. Expected survival is above three months.
- At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
- Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNL x 1.5), and renal (creatinine =< UNL) function
- The gene type of UGT1A1 *28 is 6/6 and 6/7.
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
- No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.
Exclusion Criteria:
- Non small cell lung cancer and carcinoid
- Medically uncontrolled severe diarrhea in recent three weeks.
- Inability to comply with protocol or study procedures.
- Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Pregnant or breast-feeding.
- Enrollment in other study within 30 days
- Brain metastasis with symptoms
Locations
Chongqing Cancer Hospital
Chongqing, Chongqing, China
Chongqing Zhongshan Hospita
Status: Recruiting
Contact: Qiying Li, M.D. - 13637808684
Chongqing, Chongqing, China
Xinan Hospital, Third Military Medical University
Status: Recruiting
Contact: Zhixiang Yang, M.D. - 13032372491
Chongqing, Chongqing, China
Xinqiao Hospital, Third Military Medical University
Status: Recruiting
Contact: Wei Xiong, M.D. - +86-13512345225
Chongqing, Chongqing, China
Sichuan Provincial People's Hospital
Status: Recruiting
Contact: Bo Zhu, M.D. - +86-15923366951
Chengdu, Sichuan, China
Status: Recruiting
Contact: Xueqiang Zhu, M.D. - 18981838387
Start Date
September 2013
Completion Date
September 2016
Sponsors
Third Military Medical University
Source
Third Military Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page