Ovarian Epithelial Cancer RecurrentPhase 2NCT02026921
A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer
A Phase 2 study testing Carboplatin and Docetaxel in people with Ovarian Epithelial Cancer Recurrent, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Epithelial Cancer Recurrent
- What is being tested?
- Carboplatin and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jun 2004to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- Platinum and taxane sensitive relapse
- At least one evaluable/measurable lesion.
- Adequate hematologic, renal and liver function
- Consent form signed and dated before inclusion
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Denmark2 sites
Aalborg University Hospital
Aalborg, 9000
Herlev University Hospital
Copenhagen, 2730
About this study
Official title: A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer
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.
Read the 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.
- Conditions
- Ovarian Epithelial Cancer Recurrent
- Being tested
- Carboplatin, Docetaxel
- Keywords
- Phase II study,, Recurrent platinum-sensitive ovarian cancer, docetaxel, Carboplatin, Toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
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
DocetaxelDrug
Also called Taxotere
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.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin and docetaxel | Experimental | Intravenous infusion every 3 weeks Carboplatin plus docetaxel Receives: Drug: Carboplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after last chemotherapy course
Secondary outcomes (2)
Response rate
Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR.
Measured: Up to 30 dayes after last chemotherapy course
Progression free survival
Time from start of treatment to the earlier date of assessment of progression or death by any cause.
Measured: Up to 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJun 2004
- Primary completionMar 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial Cancer RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar B Kristensen, MD, PhD, Study chair, NSGO-CTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026921
- Sponsor's protocol ID
- NSGO-OC-0303
- Status last verified
- Dec 2013
- First submitted
- 18 Dec 2013
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02026921
- Acronym / sponsor ID
- NSGO-OC-0303
- Conditions
- Ovarian Epithelial Cancer Recurrent
- Keywords
- Phase II study,, Recurrent platinum-sensitive ovarian cancer, docetaxel, Carboplatin, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials UnitUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin and docetaxel | Experimental | Drug: Carboplatin, Drug: DocetaxelIntravenous infusion every 3 weeks Carboplatin plus docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin.
- Female
- age above 18 years
- WHO performance status 0-2
- Life expectancy > 3 months
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinCarboplatin, 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 | Carboplatin and docetaxel |
| DocetaxelAlso: Taxotere75 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. | Drug | Carboplatin and docetaxel |
Primary outcome
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.
2 secondary outcomes
Response rate
Time frame: Up to 30 dayes after last chemotherapy course
Progression free survival
Time frame: Up to 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
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RecruitingPhase 1/2
Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) pt2
Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma
Active, not recruitingPhase 3
Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment
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Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
Ovary Neoplasm, Ovarian Cancer
Not yet recruitingPhase 2
Liposomal Irinotecan Plus Enlonstobart for Platinum-Resistant Recurrent Ovarian Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar B Kristensen, MD, PhD study chair
NSGO-CTU
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin and Docetaxel in people with Ovarian Epithelial Cancer Recurrent, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Finland, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Up to 30 days after last chemotherapy course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014; AzTrials last refreshed its copy on 7 Nov 2026.