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
  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 2015
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 14, 2013
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 August 21, 2014