An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors
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| ClinicalTrials.gov Identifier: NCT01040312 |
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Recruitment Status : Unknown
Verified March 2013 by Daiichi Sankyo Co., Ltd..
Recruitment status was: Active, not recruiting
First Posted : December 29, 2009
Last Update Posted : March 29, 2013
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Sponsor:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Daiichi Sankyo Co., Ltd.
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Brief Summary:
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.
| Condition or disease | Intervention/treatment |
|---|---|
| Small Cell Lung Cancer Non-small Cell Lung Cancer Cervical Cancer Ovarian Cancer Gastric Cancer (Inoperable and Recurrent) | Drug: CPT-11 and platinum analogues |
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors |
| Study Start Date : | October 2009 |
| Estimated Primary Completion Date : | March 2013 |
| Estimated Study Completion Date : | March 2014 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
| Group/Cohort | Intervention/treatment |
|---|---|
| UGT1A1 genotpyed patients |
Drug: CPT-11 and platinum analogues
platinum analogues (cisplatin, carboplatin and nedaplatin) |
Primary Outcome Measures :
- Influence of UGT1A1 genotypes on severe toxicities (ex. neutropenia) induced by CPT-11 based regimens [ Time Frame: 3 or 6 months ]
Secondary Outcome Measures :
- Influence of UGT1A1 genotypes on response rate or disease control rate [ Time Frame: 3 or 6 monhs ]
- Exploratory analysis of risk factors for severe toxicities (ex. neutropenia) induced by CPT-11 based regimens other than UGT1A1 polymorphisms. [ Time Frame: 3 or 6 months ]
Biospecimen Retention: Samples With DNA
white cells
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and gastric cancer treated with CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) in clinical practice in Japan
Criteria
Inclusion Criteria:
- Small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and gastric cancer
- Patients with UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
- Patients to receiving CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)
Exclusion Criteria:
- Contraindication of CPT-11
- ECOG PS 3-4
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040312
Locations
| Japan | |
| Department of Obstetrics and Gynecology, National Defense Medical College Hospital | |
| Tokorozawa, Saitama, Japan, 359-8513 | |
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
| Principal Investigator: | Masashi Takano, MD. PhD. | Department of Obstetrics and Gynecology, National Defense Medical College |
| Responsible Party: | Daiichi Sankyo Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01040312 History of Changes |
| Other Study ID Numbers: |
TOP009-062 |
| First Posted: | December 29, 2009 Key Record Dates |
| Last Update Posted: | March 29, 2013 |
| Last Verified: | March 2013 |
Keywords provided by Daiichi Sankyo Co., Ltd.:
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UGT1A1, irinotecan |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Stomach Neoplasms Uterine Cervical Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Bronchial Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Uterine Neoplasms Genital Neoplasms, Female |
Urogenital Neoplasms Respiratory Tract Diseases Carcinoma, Bronchogenic Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |