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

Information source: Nordic Society for Gynaecologic Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Epithelial Cancer Recurrent

Intervention: Carboplatin (Drug); Docetaxel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Nordic Society for Gynaecologic Oncology

Official(s) and/or principal investigator(s):
Gunnar B Kristensen, MD, PhD, Study Chair, Affiliation: NSGO-CTU


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.

Clinical Details

Official title: A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety

Secondary outcome:

Response rate

Progression free survival

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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


- 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

Locations and Contacts

Aalborg University Hospital, Aalborg 9000, Denmark

Herlev University Hospital, Copenhagen 2730, Denmark

Tampere University Hospital, Tampere, Finland

Norwegian Radium Hospital, Oslo 0310, Norway

Additional Information

Starting date: June 2004
Last updated: December 31, 2013

Page last updated: August 23, 2015

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