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

NCT02728622 | Completed Phase 3

• 1 other identifier: NSGO-OC-0101
• Study Type: interventional
• Target: 241
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ovarian Cancer; Peritoneal Cancer; Cancer of the Fallopian Tube

Keywords

ovarian cancer; platinum-resistant; endocrine treatment; chemotherapy; tamoxifen

Outcome Measures

Primary Outcomes (1)

• Quality-adjusted survival

  through completion of study, on average 1 year

Secondary Outcomes (2)

• progression-free survival

  through completion of study, on average 3 months

• overall survival

  through completion of study, on average 1 year

Study Arms (2)

Tamoxifen

EXPERIMENTAL

Tamoxifen 40 mg is given orally once daily until progression

Drug: Tamoxifen

Chemotherapy

ACTIVE COMPARATOR

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

Drug: Chemotherapy

Interventions

Tamoxifen DRUG

endocrine treatment

Tamoxifen

Chemotherapy DRUG

Paclitaxel or pegylated liposomal doxorubicin

Also known as: paclitaxel, pegylated liposomal doxorubicin

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Tamoxifen; Drug Therapy; Paclitaxel; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Gunnar B Kristensen, Prof

  The Norwegian Radium Hospital, Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2016
• First Posted: April 5, 2016
• Study Start: March 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2009
• Last Updated: April 5, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share