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Trial record 97 of 167 for:    pertuzumab

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

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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:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

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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


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




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004093


  Show 34 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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

Additional relevant MeSH terms:
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Pertuzumab
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Gemcitabine
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