Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse (HECTOR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00437307
First received: February 19, 2007
Last updated: November 14, 2013
Last verified: November 2013

February 19, 2007
November 14, 2013
March 2007
July 2013   (final data collection date for primary outcome measure)
progression-free survival [ Time Frame: after 1 year-follow-up ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00437307 on ClinicalTrials.gov Archive Site
overall survival, efficacy and tolerability of the regimes and quality of life [ Time Frame: during study and follow-up ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse
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

Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
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
  • 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.
    Intervention: Drug: Topotecan
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
550
September 2015
July 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00437307
3104000
Not Provided
North Eastern Germany Society of Gynaecologic Oncology
North Eastern Germany Society of Gynaecologic Oncology
Not Provided
Study Chair: Jalid Sehouli Charité Campus Vichow Klinikum
North Eastern Germany Society of Gynaecologic Oncology
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP