Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer
NCT ID: NCT01977235
Last Updated: 2016-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
110 participants
INTERVENTIONAL
2013-09-30
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Irinotecan 90mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
Irinotecan
Cisplatin
Arm B
Irinotecan 65mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
Irinotecan
Cisplatin
Interventions
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Irinotecan
Cisplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Xueqin Yang
associate chief physician
Principal Investigators
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Xueqin Yang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Daping Hospital, Third Military Medical University
Locations
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Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Xinan Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qiying Li, M.D.
Role: primary
Wei Xiong, M.D.
Role: primary
Bo Zhu, M.D.
Role: primary
References
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Hanna N, Bunn PA Jr, Langer C, Einhorn L, Guthrie T Jr, Beck T, Ansari R, Ellis P, Byrne M, Morrison M, Hariharan S, Wang B, Sandler A. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol. 2006 May 1;24(13):2038-43. doi: 10.1200/JCO.2005.04.8595.
Gao J, Zhou J, Li Y, Lu M, Jia R, Shen L. UGT1A1 6/28 polymorphisms could predict irinotecan-induced severe neutropenia not diarrhea in Chinese colorectal cancer patients. Med Oncol. 2013;30(3):604. doi: 10.1007/s12032-013-0604-x. Epub 2013 May 18.
Zhang X, Meng X, Wang Y, Yan W, Yang J. Comprehensive analysis of UGT1A1 genetic polymorphisms in Chinese Tibetan and Han populations. Biochem Genet. 2012 Dec;50(11-12):967-77. doi: 10.1007/s10528-012-9536-y. Epub 2012 Sep 16.
Noda K, Nishiwaki Y, Kawahara M, Negoro S, Sugiura T, Yokoyama A, Fukuoka M, Mori K, Watanabe K, Tamura T, Yamamoto S, Saijo N; Japan Clinical Oncology Group. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):85-91. doi: 10.1056/NEJMoa003034.
Other Identifiers
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TDICC
Identifier Type: -
Identifier Source: org_study_id
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