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

• ClinicalTrials.gov Identifier: NCT02004093
• Recruitment Status: Completed
• First Posted: December 6, 2013
• Results First Posted: December 4, 2014
• Last Update Posted: December 4, 2014
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer	Drug: pertuzumab; Drug: paclitaxel; Drug: gemcitabine; Drug: carboplatin	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 149 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: December 2005
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Chemotherapy + Pertuzumab	Drug: pertuzumab; Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks; Drug: paclitaxel; 175 mg/m2 IV every 3 weeks for 6 cycles; Drug: gemcitabine; 1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles; Drug: carboplatin; Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
Active Comparator: Chemotherapy	Drug: paclitaxel; 175 mg/m2 IV every 3 weeks for 6 cycles; Drug: gemcitabine; 1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles; Drug: carboplatin; Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. 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 ]
   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".
2. 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 ]
   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.
3. Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year [ Time Frame: 1 year ]
4. 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 ]
   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.
5. 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 ]
   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.
6. Kaplan-Meier Probability of Being Progression Free at 1 Year [ Time Frame: 1 year ]
7. 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 ]
   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.
8. 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 ]
9. 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 ]
   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.
10. Kaplan-Meier Probability of Being Alive at 1 Year [ Time Frame: 1 year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Belgium

Bruxelles, Belgium, 1000

Leuven, Belgium, 3000

Wilrijk, Belgium, 2610

Canada, Alberta

Calgary, Alberta, Canada, T2N 4N2

Canada, British Columbia

Kelowna, British Columbia, Canada, V1Y 5L3

Vancouver, British Columbia, Canada, V5Z 4E6

Hungary

Budapest, Hungary, 1122

Debrecen, Hungary, 4032

Gyor, Hungary, 9024

Italy

Parma, Emilia-Romagna, Italy, 43100

Milano, Lombardia, Italy, 20133

Netherlands

Amsterdam, Netherlands, 1066 CX

Amsterdam, Netherlands, 1081 HV

Poland

Poznan, Poland, 60-535

Warszawa, Poland, 02-781

Russian Federation

Kazan, Russian Federation, 420029

Moscow, Russian Federation, 105203

Moscow, Russian Federation, 115478

Moscow, Russian Federation, 117837

Moscow, Russian Federation, 125284

Moscow, Russian Federation, 143423

Saint-Petersburg, Russian Federation, 197022

St Petersburg, Russian Federation, 197758

Tomsk, Russian Federation, 634028

Spain

Barcelona, Spain, 08035

Barcelona, Spain, 08036

Madrid, Spain, 28041

Valencia, Spain, 46009

United Kingdom

Birmingham, United Kingdom, B18 7QH

London, United Kingdom, W12 OHS

Manchester, United Kingdom, M20 4BX

Plymouth, United Kingdom, PL6 8DH

Sutton, United Kingdom, SM2 5PT

Yeovil, United Kingdom, BA21 4AT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Chair: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02004093
• Other Study ID Numbers: BO17931
• First Posted: December 6, 2013
• Results First Posted: December 4, 2014
• Last Update Posted: December 4, 2014
• Last Verified: November 2014

Additional relevant MeSH terms:

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pertuzumab; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Gemcitabine; Paclitaxel; Carboplatin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents