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

NCT01040312 | Completed DMC

• 2 other identifiers: TOP009-062090946
• Study Type: observational
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer; Non-small Cell Lung Cancer; Cervical Cancer; Ovarian Cancer; Gastric Cancer (Inoperable and Recurrent)

Keywords

UGT1A1, irinotecan

Outcome Measures

Primary Outcomes (1)

• Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues

  within 6 months

Secondary Outcomes (2)

• Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues

  within 6 months

• Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype

  within 6 months

Study Arms (1)

UGT1A1 genotyped patients

UGT1A1 genotyped patients receive CPT-11 with platinum analogues

Drug: CPT-11; Drug: Platinum analogues

Interventions

CPT-11 DRUG

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.

Also known as: Camptosar, Topotecin

UGT1A1 genotyped patients

Platinum analogues DRUG

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.

Also known as: Cisplatin, Carboplatin, Nedaplatin

UGT1A1 genotyped patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Has contraindication for CPT-11
• Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Department of Obstetrics and Gynecology, National Defense Medical College Hospital

Tokorozawa, 359-8513, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

white cells

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Ovarian Neoplasms; Stomach Neoplasms; Recurrence

Interventions

Irinotecan; Cisplatin; Carboplatin; nedaplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Clinical Study Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 29, 2009
• Study Start: October 15, 2009
• Primary Completion: September 29, 2014
• Study Completion: September 2, 2015
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)