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

Ovarian Cancer Clinical Trial

Official title:

A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728622
• Other study ID #: NSGO-OC-0101
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2016
• Last updated: April 4, 2016
• Start date: March 2002
• Est. completion date: January 2009

Study information

• Verified date: March 2016
• Source: Nordic Society for Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: January 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Fallopian Tube
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

Drug:
• Tamoxifen
endocrine treatment
• Chemotherapy
Paclitaxel or pegylated liposomal doxorubicin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Society for Gynaecologic Oncology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality-adjusted survival		through completion of study, on average 1 year	No
Secondary	progression-free survival	time to progressive disease or death	through completion of study, on average 3 months	No
Secondary	overall survival	time to death of any cause	through completion of study, on average 1 year	No