Ovarian CancerPhase 2NCT02004093

A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer

A Phase 2 study testing pertuzumab, paclitaxel and gemcitabine in people with Ovarian Cancer, run by Hoffmann-La Roche at 34 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: pertuzumab, paclitaxel and gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 34 sitesin 9 countries
Study dates: Dec 2005to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
only 1 previous regimen, which must be platinum-based;
platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.

Who cannot join

previous radiotherapy;
previous treatment with an anti-cancer vaccine or any targeted therapy;
major surgery or traumatic injury within 4 weeks of study;
history or evidence of central nervous system metastases.

Trial locations and contacts

34 sites in 9 countries.

Country

City, postcode or hospital

34 sites in 9 countries

Russia9 sites

Study site
Kazan', 420029
Study site
Moscow, 105203
Study site
Moscow, 115478
Study site
Moscow, 117837
Study site
Moscow, 125284
Study site
Moscow, 143423
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197758
Study site
Tomsk, 634028

Other trials in Russia

United Kingdom6 sites

Study site
Birmingham, B18 7QH
Study site
London, W12 OHS
Study site
Manchester, M20 4BX
Study site
Plymouth, PL6 8DH
Study site
Sutton, SM2 5PT
Study site
Yeovil, BA21 4AT

Other trials in United Kingdom

Spain4 sites

Study site
Barcelona, Barcelona, 08035
Study site
Barcelona, Barcelona, 08036
Study site
Madrid, Madrid, 28041
Study site
Valencia, Valencia, 46009

Other trials in Spain

Belgium3 sites

Study site
Brussels, 1000
Study site
Leuven, 3000
Study site
Wilrijk, 2610

Other trials in Belgium

Canada3 sites

Study site
Calgary, Alberta, T2N 4N2
Study site
Kelowna, British Columbia, V1Y 5L3
Study site
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Hungary3 sites

Study site
Budapest, 1122
Study site
Debrecen, 4032
Study site
Győr, 9024

Other trials in Hungary

Italy2 sites

Study site
Milan, Lombardy, 20133
Study site
Parma, Emilia-Romagna, 43100

Other trials in Italy

Netherlands2 sites

Study site
Amsterdam, 1066 CX
Study site
Amsterdam, 1081 HV

Other trials in Netherlands

Poland2 sites

Study site
Poznan, 60-535
Study site
Warsaw, 02-781

Other trials in Poland

About this study

Official title: A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Conditions: Ovarian Cancer
Being tested: pertuzumab, paclitaxel, gemcitabine, carboplatin
Medical subject headings: Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pertuzumabDrug
Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
paclitaxelDrug
175 mg/m2 IV every 3 weeks for 6 cycles
gemcitabineDrug
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
carboplatinDrug
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Study groups in NCT02004093
Study group	Role	What they receive
Chemotherapy + Pertuzumab	Experimental	Not described Receives: Drug: pertuzumab; Drug: paclitaxel; Drug: gemcitabine; Drug: carboplatin
Chemotherapy	Active comparator	Not described Receives: Drug: paclitaxel; Drug: gemcitabine; Drug: carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Disease Progression or Death
Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Measured: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Progression-Free Survival
Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Measured: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Kaplan-Meier Probability of No Disease or Progression at 1 Year
The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
Measured: 1 year

Secondary outcomes (10)

Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were "response", "stable disease" and "progressive disease". Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".
Measured: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Duration of Response
For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.
Measured: Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
Measured: 1 year
Percentage of Participants With Disease Progression
Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Measured: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Time to Progressive Disease
The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.
Measured: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Kaplan-Meier Probability of Being Progression Free at 1 Year
Measured: 1 year
Time To Response
Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.
Measured: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Percentage of Participants Who Died
Measured: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Overall Survival
Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.
Measured: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Kaplan-Meier Probability of Being Alive at 1 Year
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Sep 2008

First posted6 Dec 2013 (estimated)
Study startDec 2005
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02004093
Sponsor's protocol ID: BO17931
Status last verified: Nov 2014
First submitted: 3 Dec 2013
Last updated: 4 Dec 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT02004093
Acronym / sponsor ID: BO17931
Conditions: Ovarian Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Posted 4 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Chemotherapy + Pertuzumab	Experimental	Drug: pertuzumab, Drug: paclitaxel, Drug: gemcitabine, Drug: carboplatin
Chemotherapy	Active comparator	Drug: paclitaxel, Drug: gemcitabine, Drug: carboplatin

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
only 1 previous regimen, which must be platinum-based;
platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.

Key exclusion criteria (4 listed)

previous radiotherapy;
previous treatment with an anti-cancer vaccine or any targeted therapy;
major surgery or traumatic injury within 4 weeks of study;
history or evidence of central nervous system metastases.

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
pertuzumabLoading dose of 840 mg IV, followed by 420 mg IV every 3 weeks	Drug	Chemotherapy + Pertuzumab
paclitaxel175 mg/m2 IV every 3 weeks for 6 cycles	Drug	Chemotherapy, Chemotherapy + Pertuzumab
gemcitabine1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles	Drug	Chemotherapy, Chemotherapy + Pertuzumab
carboplatinTarget AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles	Drug	Chemotherapy, Chemotherapy + Pertuzumab

Primary outcome

Percentage of Participants With Disease Progression or Death
Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Progression-Free Survival
Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Kaplan-Meier Probability of No Disease or Progression at 1 Year
Time frame: 1 year
The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.

10 secondary outcomes

Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Duration of Response
Time frame: Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
Time frame: 1 year
Percentage of Participants With Disease Progression
Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Time to Progressive Disease
Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
Kaplan-Meier Probability of Being Progression Free at 1 Year
Time frame: 1 year
Time To Response
Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Percentage of Participants Who Died
Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Overall Survival
Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
Kaplan-Meier Probability of Being Alive at 1 Year
Time frame: 1 year

Results and safety

Results posted to the registry on 4 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chemotherapy + Pertuzumab	75	1
Chemotherapy	74	1

Primary outcome: Percentage of Participants With Disease Progression or Death

Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks. Number. Unit: percentage of participants

Measure	Chemotherapy + Pertuzumab n = 74	Chemotherapy n = 75
Value	87.8	80.0

Population analysed: All treated participants who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.

Primary outcome: Progression-Free Survival

Time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks. Median (Full Range). Unit: weeks

Measure	Chemotherapy + Pertuzumab n = 74	Chemotherapy n = 75
Value	34.1 (31 to 38)	40.0 (33 to 43)

Chemotherapy + Pertuzumab vs Chemotherapy: p = 0.3967, Log Rank
Chemotherapy + Pertuzumab vs Chemotherapy: p = 0.4552, Wilcoxon (Mann-Whitney)
Chemotherapy + Pertuzumab vs Chemotherapy: Hazard Ratio (HR): 1.17 (80% CI 0.92 to 1.49), p = 0.3972, Wald test

Population analysed: All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.

Primary outcome: Kaplan-Meier Probability of No Disease or Progression at 1 Year

Time frame: 1 year. Number. Unit: percent

Measure	Chemotherapy + Pertuzumab n = 74	Chemotherapy n = 75
Value	24	21

Population analysed: All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 17 and 12 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the date of randomization until 28 days after the last dose of the pertuzumab and/ or standard chemotherapy and continuously until end of study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chemotherapy + Pertuzumab	20 of 75 (26.7%)	72 of 75 (96%)	Not reported
Chemotherapy	12 of 74 (16.2%)	68 of 74 (91.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 2
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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.

Clinical Trials study chair

Hoffmann-La Roche

34 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pertuzumab, paclitaxel and gemcitabine in people with Ovarian Cancer, run by Hoffmann-La Roche at 34 sites in 9 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 3 inclusion and 4 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 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Russia, United Kingdom, Spain, Belgium, Canada and 4 more countries. 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?

Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Disease Progression or Death (time frame: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02004093.

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 4 Dec 2014.