Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse - Full Text View

Sponsored by:	North Eastern Germany Society of Gynaecologic Oncology
Information provided by:	North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:	NCT00437307

Purpose

Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

Condition	Intervention	Phase
Ovarian Cancer	Drug: Topotecan	Phase III

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Paclitaxel Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-Sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom

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

Primary Outcome Measures:

progression-free survival [ Time Frame: after 1 year-follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

overall survival, efficacy and tolerability of the regimes and quality of life [ Time Frame: during study and follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	550
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Topotecan: 0,75 mg/m²/d, Tage 1-3 und Carboplatin: AUC 5 (after Cockroft and Gault formula) am Tag 3 nach Topotecan, q 21d.	Drug: Topotecan Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d
2: No Intervention Paclitaxel 175 mg/m2/d, day 1 and Carboplatin: AUC 5 (after Cockroft and Gault formula), day 1, q21d OR gemcitabine 1000 mg/m2/d, day 1 and 8 and Carboplatin AUC 4 (after Cockroft and Gault formula), day 1, q 21d.

Detailed Description:

In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability.

It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
All patients will provide written informed consent

Exclusion Criteria:

Patients with more than two chemotherapies in their history
Progress less than six months after completion of primary standard therapy
Simultaneous or planned radiation
Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
Patients with infection
Patients who are pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437307

Contacts

Contact: Jalid Sehouli

030/ 450 564 052

Locations

Germany
Charité Campus Virchow Klinikum	Recruiting
Berlin, Germany, 13353
Contact: Jalid Sehouli 030/ 450 564 052 studiensekretariat.agovarialca@charite.de
Principal Investigator: Jalid Sehouli

Sponsors and Collaborators

North Eastern Germany Society of Gynaecologic Oncology

Investigators

Study Chair:

Jalid Sehouli

Charité Campus Vichow Klinikum

More Information

Responsible Party:	Charité Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin ( Jalid Sehouli, Prof. Dr. med. )
Study ID Numbers:	3104000
Study First Received:	February 19, 2007
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00437307
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

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

Carboplatin
Genital Diseases, Female
Paclitaxel
Endocrinopathy
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 15, 2009