Chemotherapy vs Hormonal Treatment in Platinum-resistant Ovarian Cancer Resistant or Refractory to Platinum and Taxane

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Status and phase: Completed; Phase 3

Conditions: Cancer of the Fallopian Tube; Peritoneal Cancer; Ovarian Cancer

Treatments: Drug: Chemotherapy; Drug: Tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT02728622

NSGO-OC-0101

Details and patient eligibility

About

A randomized study of chemotherapy versus hormonal treatment in patients with ovarian cancer resistant or refractory to platinum and taxane.

Full description

Patients with platinum-resistant invasive epithelial ovarian, fallopian tube or peritoneal cancer will be randomized 1:2 to either hormonal treatment with Tamoxifen 40 mg daily or chemotherapy of investigator's choice (weekly paclitaxel given as an 1 hour infusion of paclitaxel 80 mg/m2 or pegylated liposomal doxorubicin 40 mg/m2 given every 4 weeks).

Enrollment: 241 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially.
• Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse.
• Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated.
• Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse.
• Age must be at least 18 years.
• Performance status must be 0-2 (WHO/ECOG, appendix 1).
• Informed consent given according to ICH/EU GCP guidelines and local or national laws

Exclusion criteria

• Patients with symptomatic brain metastasis
• Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L.
• Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed.
• Pregnant, lactating, or child bearing potential patients without adequate contraception
• Previous treatment with Tamoxifen.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 2 patient groups

Tamoxifen

Experimental group

Description:

Tamoxifen 40 mg is given orally once daily until progression

Treatment:

Drug: Tamoxifen

Chemotherapy

Active Comparator group

Description:

Paclitaxel 80 mg/m2 is given as an 1 hour infusion every 7 days or Caelyx 40 mg/m2 is given iv, first dose over 2 hours, later doses are infused over 1 hour, administered every 4 weeks or up to a maximum dose of 550 mg/m2. Until progression

Treatment:

Drug: Chemotherapy