A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02026921
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : January 3, 2014
Information provided by (Responsible Party):
Nordic Society for Gynaecologic Oncology

Brief Summary:

A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer.

Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Recurrent Drug: Carboplatin Drug: Docetaxel Phase 2

Detailed Description:
Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer
Study Start Date : June 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Carboplatin and docetaxel
Intravenous infusion every 3 weeks Carboplatin plus docetaxel
Drug: Carboplatin
Carboplatin, AUC5, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops

Drug: Docetaxel
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.
Other Name: Taxotere

Primary Outcome Measures :
  1. Safety [ Time Frame: Up to 30 days after last chemotherapy course ]
    Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 2.0). All toxicities observed within 30 dayes of last chemocourse will be included.

Secondary Outcome Measures :
  1. Response rate [ Time Frame: Up to 30 dayes after last chemotherapy course ]
    Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR.

  2. Progression free survival [ Time Frame: Up to 3 year ]
    Time from start of treatment to the earlier date of assessment of progression or death by 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

Inclusion Criteria:

  • Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin.
  • Female
  • age above 18 years
  • WHO performance status 0-2
  • Life expectancy > 3 months
  • Previous treatment with one platinum and taxane containing regimen.
  • Platinum and taxane sensitive relapse
  • At least one evaluable/measurable lesion.
  • Adequate hematologic, renal and liver function
  • Consent form signed and dated before inclusion

Exclusion Criteria:

  • Prior treatment with more than one line of chemotherapy
  • Concurrent severe and/or uncontrolled co-morbid medical condition.
  • History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock
  • Pregnant or lactating women (or potentially fertile women not using adequate contraception)
  • Peripheral neuropathy > Grade 2
  • History of allergy to drugs containing the excipient TWEEN 80®.
  • Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy
  • Clinical evidence of brain metastases

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 identifier (NCT number): NCT02026921

Aalborg University Hospital
Aalborg, Denmark, 9000
Herlev University Hospital
Copenhagen, Denmark, 2730
Tampere University Hospital
Tampere, Finland
Norwegian Radium Hospital
Oslo, Norway, 0310
Sponsors and Collaborators
Nordic Society for Gynaecologic Oncology
Study Chair: Gunnar B Kristensen, MD, PhD NSGO-CTU

Responsible Party: Nordic Society for Gynaecologic Oncology Identifier: NCT02026921     History of Changes
Other Study ID Numbers: NSGO-OC-0303
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: December 2013

Keywords provided by Nordic Society for Gynaecologic Oncology:
Phase II study,
Recurrent platinum-sensitive ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action