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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Society for Gynaecologic Oncology; Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Treatments: Albumin-Bound Paclitaxel; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Tamoxifen; Taxane

Criteria

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.