Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

This study is ongoing, but not recruiting participants.

Sponsored by:	North Eastern Germany Society of Gynaecologic Oncology
Information provided by:	North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:	NCT00170625

Purpose

Compatibility of the topotecan therapy in combination with carboplatin.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Hycamtin	Phase I Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Topotecan hydrochloride Topotecan

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Prospective Phase-I/II-Study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer

Further study details as provided by North Eastern Germany Society of Gynaecologic Oncology:

Primary Outcome Measures:

Secondary Outcome Measures:

progression-free survival [ Time Frame: every 3 cycle ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	June 2004
Estimated Study Completion Date:	September 2010

Intervention Details:

Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d

Eligibility

Criteria

Inclusion Criteria:

Age >= 18 years
patient with ovarian cancer after primary therapy
bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl
renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min
liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
ECOG <= 2
Intention of regular follow-up visits for the duration of the study
written informed consent

Exclusion Criteria:

any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
ECOG > 2
patients with radiotherapy within the last 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170625

Sponsors and Collaborators

North Eastern Germany Society of Gynaecologic Oncology

Investigators

Principal Investigator:

Jalid Sehouli

Charité Campus Virchow Klinikum

More Information

Study ID Numbers:	310300
Study First Received:	September 9, 2005
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00170625
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:

platin-resistant

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases

Urogenital Neoplasms
Carboplatin
Endocrinopathy
Ovarian Diseases
Topotecan
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009