Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

Small Cell Lung Carcinoma Clinical Trial

— TDICC  

Official title:

An Open, Randomized, Parallel Control, Multiple-center Phase II Trial of Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01977235
• Other study ID #: TDICC
• 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

• Lung Neoplasms
• Small Cell Lung Carcinoma

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