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An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors

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ClinicalTrials.gov Identifier: NCT01040312
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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 Drug: Platinum analogues

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Study Type : Observational
Actual Enrollment : 321 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
Actual Study Start Date : October 15, 2009
Actual Primary Completion Date : September 29, 2014
Actual Study Completion Date : September 2, 2015


Group/Cohort Intervention/treatment
UGT1A1 genotyped patients
UGT1A1 genotyped patients receive CPT-11 with platinum analogues
Drug: CPT-11
CPT-11 blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog.
Other Names:
  • Camptosar
  • Topotecin

Drug: Platinum analogues
Platinum compounds produce changes in DNA structure, which causes cancer cell death (apoptosis). They are typically used alone or in combination with other chemotherapy drugs.
Other Names:
  • Cisplatin
  • Carboplatin
  • Nedaplatin




Primary Outcome Measures :
  1. Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues [ Time Frame: within 6 months ]

Secondary Outcome Measures :
  1. Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues [ Time Frame: within 6 months ]
  2. Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype [ Time Frame: within 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 in Japan with small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer treated with CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) in clinical practice
Criteria

Inclusion Criteria:

  • Has small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer
  • Has UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
  • Is receiving CPT-11 plus platinum analogue (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)

Exclusion Criteria:

  • Has contraindication for CPT-11
  • Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 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
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Japan
Department of Obstetrics and Gynecology, National Defense Medical College Hospital
Tokorozawa, Japan, 359-8513
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Clinical Study Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT01040312     History of Changes
Other Study ID Numbers: TOP009-062
090946 ( Other Identifier: JAPIC ID )
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
UGT1A1, irinotecan
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action