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

Primary Purpose

Ovarian Cancer

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Topotecan

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Charité Campus Virchow Klinikum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

overall survival, efficacy and tolerability of the regimes and quality of life

Full Information

NCT ID

NCT00437307

First Posted

February 19, 2007

Last Updated

September 21, 2016

Sponsor

North Eastern German Society of Gynaecological Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00437307

Brief Title

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

Acronym

HECTOR

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

North Eastern German Society of Gynaecological Oncology

4. Oversight

5. Study Description

Brief Summary

Determination of progression free survival after 12 months of FU Determination of total survival, response and quality of life

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

550 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Topotecan

Other Intervention Name(s)

Hycamtin

Intervention Description

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

Primary Outcome Measure Information:

Title

progression-free survival

Time Frame

after 1 year-follow-up

Secondary Outcome Measure Information:

Title

overall survival, efficacy and tolerability of the regimes and quality of life

Time Frame

during study and follow-up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jalid Sehouli

Organizational Affiliation

Charité Campus Vichow Klinikum

Official's Role

Study Chair

Facility Information:

Facility Name

Charité Campus Virchow Klinikum

City

Berlin

ZIP/Postal Code

13353

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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