Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00170625 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Results First Posted
: February 6, 2017
Last Update Posted
: February 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Drug: Hycamtin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Hycamtin |
Drug: Hycamtin
Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d
|
- Toxicity [ Time Frame: after each cycle for up to one year ]hematological adverse events and non-hematological adverse events grade 3/4
- Progression-free Survival [ Time Frame: after every third cycle, for up to one year ]progression-free survival according to kaplan-meier-estimator

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170625
Principal Investigator: | Jalid Sehouli | Charite University, Berlin, Germany |
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 |
First Posted: | September 15, 2005 Key Record Dates |
Results First Posted: | February 6, 2017 |
Last Update Posted: | February 6, 2017 |
Last Verified: | December 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 |