Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse (HECTOR)
This study is ongoing, but not recruiting participants.
Sponsor:
North Eastern Germany Society of Gynaecologic Oncology
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00437307
First received: February 19, 2007
Last updated: July 26, 2012
Last verified: July 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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
Other Name: Hycamtin
|
|
No Intervention: 2
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
Locations
| Germany | |
| Charité Campus Virchow Klinikum | |
| Berlin, Germany, 13353 | |
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Investigators
| Study Chair: | Jalid Sehouli | Charité Campus Vichow Klinikum |
More Information
No publications provided
| Responsible Party: | North Eastern Germany Society of Gynaecologic Oncology |
| ClinicalTrials.gov Identifier: | NCT00437307 History of Changes |
| Other Study ID Numbers: | 3104000 |
| Study First Received: | February 19, 2007 |
| Last Updated: | July 26, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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 Therapeutic Uses Pharmacologic Actions Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013