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

North Eastern German Society of Gynaecological Oncology

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Topotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT00437307

3104000

Details and patient eligibility

About

Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

Full 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.

Enrollment: 550 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

1

Active Comparator group

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.

Treatment:

Drug: Topotecan

2

No Intervention group

Description:

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.