A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer
Primary Purpose
Ovarian Epithelial Cancer Recurrent
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carboplatin
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Epithelial Cancer Recurrent focused on measuring Phase II study,, Recurrent platinum-sensitive ovarian cancer, docetaxel, Carboplatin, Toxicity
Eligibility 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
Sites / Locations
- Aalborg University Hospital
- Herlev University Hospital
- Tampere University Hospital
- Norwegian Radium Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Carboplatin and docetaxel
Arm Description
Intravenous infusion every 3 weeks Carboplatin plus docetaxel
Outcomes
Primary Outcome Measures
Safety
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
Response rate
Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR.
Progression free survival
Time from start of treatment to the earlier date of assessment of progression or death by any cause.
Full Information
NCT ID
NCT02026921
First Posted
December 18, 2013
Last Updated
December 31, 2013
Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
1. Study Identification
Unique Protocol Identification Number
NCT02026921
Brief Title
A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer
Official Title
A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Epithelial Cancer Recurrent
Keywords
Phase II study,, Recurrent platinum-sensitive ovarian cancer, docetaxel, Carboplatin, Toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carboplatin and docetaxel
Arm Type
Experimental
Arm Description
Intravenous infusion every 3 weeks Carboplatin plus docetaxel
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
Up to 30 days after last chemotherapy course
Secondary Outcome Measure Information:
Title
Response rate
Description
Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR.
Time Frame
Up to 30 dayes after last chemotherapy course
Title
Progression free survival
Description
Time from start of treatment to the earlier date of assessment of progression or death by any cause.
Time Frame
Up to 3 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar B Kristensen, MD, PhD
Organizational Affiliation
NSGO-CTU
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Herlev University Hospital
City
Copenhagen
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer
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