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Status unknownNCT01977235TDICCUpdated Apr 1, 2016

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

A Phase 2 interventional study of Irinotecan and Cisplatin in Small Cell Lung Carcinoma, sponsored by Third Military Medical University. Status unknown at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-01.

Sponsored by Third Military Medical University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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).

02

Conditions studied

  • Small Cell Lung Carcinoma

Keywords

  • Irinotecan; Cisplatin; Small-cell lung cancer; UGT1A1
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 110 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Irinotecan · Drug: Cisplatin

  • Active comparator
    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.

    Drug: Irinotecan · Drug: Cisplatin

Interventions

  • DrugIrinotecan
  • DrugCisplatin
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What researchers measure

Primary outcomes

  1. progression-free survival

    Time frame: The first day of treatment to the date that disease progression is reported; assessed up to 3 years

Secondary outcomes

  1. overall survival

    Time frame: the first day of treatment to death or last survival confirm date; assesed up to 3 years

  2. Tumor response rate

    the ratio between the number of responders and number of patients assessable for tumor response

    Time frame: Up to 3 years

  3. Toxicity

    Time frame: the first date of treatment to 30 days after the last dose of study drug

  4. Quality of life

    Time frame: the day before every cycle of chemotherapy; 30 days after the last dose of study drug

07

Study locations

3 of 3 sites recruiting
  • Chongqing Cancer Hospital
    Chongqing, Chongqing, China
    • Qiying Li, M.D. · Contact · 13637808684
    • Qiying Li, M.D. · Principal investigator
    • Dairong Li · Principal investigator
    Recruiting
  • Xinan Hospital, Third Military Medical University
    Chongqing, Chongqing, China
    • Wei Xiong, M.D. · Contact · +86-13512345225
    • Wei Xiong · Principal investigator
    Recruiting
  • Xinqiao Hospital, Third Military Medical University
    Chongqing, Chongqing, China
    • Bo Zhu, M.D. · Contact · +86-15923366951
    • Bo Zhu, M.D. · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 16648503 ↗
  • 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. PubMed 23686699 ↗
  • 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. PubMed 22983686 ↗
  • 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. PubMed 11784874 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01977235
Lead sponsor
Third Military Medical University
Responsible party
Xueqin Yang (associate chief physician, Third Military Medical University) — Principal investigator
First posted
Nov 6, 2013
Start date
Sep 2013
Primary completion
Feb 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Apr 1, 2016

Study contacts

Xueqin Yang, M.D.
Contact
yangxueqin@hotmail.com
+86-023-68757158
Xueqin Yang, M.D.
principal investigator · Daping Hospital, Third Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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