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

March 31, 2016 updated by: Xueqin Yang, Third Military Medical University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing Cancer Hospital
        • Contact:
          • Qiying Li, M.D.
          • Phone Number: 13637808684
        • Principal Investigator:
          • Qiying Li, M.D.
        • Principal Investigator:
          • Dairong Li
      • Chongqing, Chongqing, China
        • Recruiting
        • Xinan Hospital, Third Military Medical University
        • Contact:
          • Wei Xiong, M.D.
          • Phone Number: +86-13512345225
        • Principal Investigator:
          • Wei Xiong
      • Chongqing, Chongqing, China
        • Recruiting
        • Xinqiao Hospital, Third Military Medical University
        • Contact:
          • Bo Zhu, M.D.
          • Phone Number: +86-15923366951
        • Principal Investigator:
          • Bo Zhu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Cisplatin
Drug: Irinotecan
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: Cisplatin
Drug: Irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: The first day of treatment to the date that disease progression is reported; assessed up to 3 years
The first day of treatment to the date that disease progression is reported; assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: the day before every cycle of chemotherapy; 30 days after the last dose of study drug
the day before every cycle of chemotherapy; 30 days after the last dose of study drug
Toxicity
Time Frame: the first date of treatment to 30 days after the last dose of study drug
the first date of treatment to 30 days after the last dose of study drug
overall survival
Time Frame: the first day of treatment to death or last survival confirm date; assesed up to 3 years
the first day of treatment to death or last survival confirm date; assesed up to 3 years
Tumor response rate
Time Frame: Up to 3 years
the ratio between the number of responders and number of patients assessable for tumor response
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Principal Investigator: Xueqin Yang, M.D., Daping Hospital, Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDICC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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