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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01977235
Other study ID # TDICC
Secondary ID
Status Recruiting
Phase Phase 2
First received October 15, 2013
Last updated March 31, 2016
Start date September 2013
Est. completion date September 2017

Study information

Verified date March 2016
Source Third Military Medical University
Contact Xueqin Yang, M.D.
Phone +86-023-68757158
Email yangxueqin@hotmail.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date September 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Irinotecan

Cisplatin


Locations

Country Name City State
China Chongqing Cancer Hospital Chongqing Chongqing
China Xinan Hospital, Third Military Medical University Chongqing Chongqing
China Xinqiao Hospital, Third Military Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary progression-free survival The first day of treatment to the date that disease progression is reported; assessed up to 3 years No
Secondary overall survival the first day of treatment to death or last survival confirm date; assesed up to 3 years No
Secondary Tumor response rate the ratio between the number of responders and number of patients assessable for tumor response Up to 3 years No
Secondary Toxicity the first date of treatment to 30 days after the last dose of study drug Yes
Secondary Quality of life the day before every cycle of chemotherapy; 30 days after the last dose of study drug No
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