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Small Cell Lung CarcinomaPhase 2TDICCNCT01977235

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

A Phase 2 study testing Irinotecan and Cisplatin in people with Small Cell Lung Carcinoma, run by Third Military Medical University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Irinotecan and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
3 sitesChina
Study dates
Sep 2013to Sep 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Xueqin Yang, M.D. contact

+86-023-68757158

yangxueqin@hotmail.com

China3 sites, 3 recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

    Qiying Li, M.D., 13637808684

    Qiying Li, M.D.

    Recruiting

  • Xinan Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality

    Wei Xiong, M.D., +86-13512345225

    Wei Xiong

    Recruiting

  • Xinqiao Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality

    Bo Zhu, M.D., +86-15923366951

    Bo Zhu, M.D.

    Recruiting

Other trials in China

About this study

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

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).

Being tested
Irinotecan, Cisplatin
Keywords
Irinotecan; Cisplatin; Small-cell lung cancer; UGT1A1
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01977235
Study groupRoleWhat they receive
Arm AExperimentalIrinotecan 90mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
Receives: Drug: Irinotecan; Drug: Cisplatin
Arm BActive comparatorIrinotecan 65mg/m2/iv over 90min and cisplatin 30mg/m2/iv over 60min on day 1 and 8, repeat Q 3weeks. Four cycles.
Receives: Drug: Irinotecan; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

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

Secondary outcomes (4)

  1. overall survival

    Measured: 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

    Measured: Up to 3 years

  3. Toxicity

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

  4. Quality of life

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionFeb 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01977235
Sponsor's protocol ID
TDICC
Acronym
TDICC
Status last verified
Mar 2016
First submitted
15 Oct 2013
Last updated
1 Apr 2016
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan and Cisplatin in people with Small Cell Lung Carcinoma, run by Third Military Medical University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xueqin Yang, M.D. (+86-023-68757158, yangxueqin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: The first day of treatment to the date that disease progression is reported; assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01977235, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016.

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