To hear about similar clinical trials, please enter your email below
Trial Title:
Two Different Dosages of Irinotecan Combined With Cisplatin Scheme in Extensive Disease-Small Cell Lung Cancer
NCT ID:
NCT01977235
Condition:
Small Cell Lung Carcinoma
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Irinotecan
Conditions: Keywords:
Irinotecan; Cisplatin; Small-cell lung cancer; UGT1A1
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Cisplatin
Arm group label:
Arm A
Arm group label:
Arm B
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiying Li, M.D.
Phone:
13637808684
Investigator:
Last name:
Qiying Li, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Dairong Li
Email:
Principal Investigator
Facility:
Name:
Xinan Hospital, Third Military Medical University
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Xiong, M.D.
Phone:
+86-13512345225
Investigator:
Last name:
Wei Xiong
Email:
Principal Investigator
Facility:
Name:
Xinqiao Hospital, Third Military Medical University
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Zhu, M.D.
Phone:
+86-15923366951
Investigator:
Last name:
Bo Zhu, M.D.
Email:
Principal Investigator
Start date:
September 2013
Completion date:
September 2017
Lead sponsor:
Agency:
Third Military Medical University
Agency class:
Other
Source:
Third Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01977235
