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Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer
This study has been completed.
Sponsor:
North Eastern Germany Society of Gynaecologic Oncology
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00170625
First received: September 9, 2005
Last updated: December 13, 2016
Last verified: December 2016
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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: | 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
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 for up to one year ]hematological adverse events and non-hematological adverse events grade 3/4
Secondary Outcome Measures:
- Progression-free Survival [ Time Frame: after every third cycle, for up to one year ]progression-free survival according to kaplan-meier-estimator
| Enrollment: | 28 |
| 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) |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00170625
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 | Charite University, Berlin, Germany |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Results First Received: | October 4, 2016 |
| Last Updated: | December 13, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 July 19, 2017