Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

North Eastern Germany Society of Gynaecologic Oncology

ClinicalTrials.gov Identifier:

NCT00170625

First received: September 9, 2005

Last updated: March 24, 2016

Last verified: March 2016

History of Changes

Purpose

Compatibility of the topotecan therapy in combination with carboplatin.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Hycamtin	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Ovarian Cancer

Drug Information available for: Carboplatin Topotecan hydrochloride Topotecan

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Toxicity [ Time Frame: after each cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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


Enrollment:	36
Study Start Date:	June 2004
Study Completion Date:	September 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Hycamtin	Drug: Hycamtin Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fotopoulou C, Karavas A, Trappe R, Chekerov R, Lichtenegger W, Sehouli J. Venous thromboembolism in recurrent ovarian cancer-patients: A systematic evaluation of the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Thromb Res. 2009 Nov;124(5):531-5. doi: 10.1016/j.thromres.2009.03.013. Epub 2009 May 8.


Responsible Party:	North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:	NCT00170625 History of Changes
Other Study ID Numbers:	310300
Study First Received:	September 9, 2005
Last Updated:	March 24, 2016
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:


platin-resistant

Additional relevant MeSH terms:


Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms	Endocrine System Diseases Gonadal Disorders Carboplatin Topotecan Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016

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