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