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

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ClinicalTrials.gov Identifier: NCT02728622
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Nordic Society of Gynaecological Oncology - Clinical Trials Unit ( Nordic Society for Gynaecologic Oncology )

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cancer Cancer of the Fallopian Tube Drug: Tamoxifen Drug: Chemotherapy Phase 3

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study of Chemotherapy Versus Hormonal Treatment in Patients With Ovarian Cancer Resistant or Refractory to Platinum and Taxane
Study Start Date : March 2002
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2009


Arm Intervention/treatment
Experimental: Tamoxifen
Tamoxifen 40 mg is given orally once daily until progression
Drug: Tamoxifen
endocrine treatment

Active Comparator: Chemotherapy
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
Paclitaxel or pegylated liposomal doxorubicin
Other Names:
  • paclitaxel
  • pegylated liposomal doxorubicin




Primary Outcome Measures :
  1. Quality-adjusted survival [ Time Frame: through completion of study, on average 1 year ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: through completion of study, on average 3 months ]
    time to progressive disease or death

  2. overall survival [ Time Frame: through completion of study, on average 1 year ]
    time to death of any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728622


Sponsors and Collaborators
Nordic Society for Gynaecologic Oncology
Investigators
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Study Chair: Gunnar B Kristensen, Prof The Norwegian Radium Hospital, Oslo University Hospital
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Responsible Party: Nordic Society for Gynaecologic Oncology
ClinicalTrials.gov Identifier: NCT02728622    
Other Study ID Numbers: NSGO-OC-0101
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nordic Society of Gynaecological Oncology - Clinical Trials Unit ( Nordic Society for Gynaecologic Oncology ):
ovarian cancer
platinum-resistant
endocrine treatment
chemotherapy
tamoxifen
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Tamoxifen
Paclitaxel
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors