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A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635489
Recruitment Status : Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose disease has not progressed after six cycles of paclitaxel and carboplatin with either bevacizumab or placebo will continue treatment with either bevacizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs first.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Drug: Paclitaxel Drug: Bevacizumab Drug: Carboplatin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin Paclitaxel Plus Concurrent and Extended Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated, Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : December 29, 2020
Estimated Study Completion Date : May 6, 2021


Arm Intervention/treatment
Experimental: Bevacizumab + Paclitaxel + Carboplatin
Participants will receive paclitaxel, carboplatin intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting from Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab for a total of 21 cycles of bevacizumab in the absence of disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Drug: Paclitaxel
175 mg/m^2 IV infusion on Day 1 of each 21-day cycle.

Drug: Bevacizumab
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Other Name: Avastin

Drug: Carboplatin
Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.

Placebo Comparator: Placebo + Paclitaxel + Carboplatin
Participants will receive paclitaxel, carboplatin IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and placebo IV infusion starting from Cycle 2 for a total of 5 cycles, followed by maintenance therapy placebo for a total of 21 cycles of placebo in the absence of disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Drug: Paclitaxel
175 mg/m^2 IV infusion on Day 1 of each 21-day cycle.

Drug: Carboplatin
Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.

Drug: Placebo
Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) ]
    PFS was defined as time from randomization to the first occurrence of disease progression, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization up to to death from any cause (up to approximately 24 months) ]
    OS was defined as the time from the date of randomization to the date of death from any cause.

  2. Objective Response Rate (ORR) [ Time Frame: Randomization up to disease progression or death from any cause, whichever occurs first (up to approximately 24 months) ]
    ORR was defined as the proportion of participants with complete response (CR) or partial response (PR) as assessed by investigator according to RECIST v.1.1.

  3. Duration of Response (DOR) [ Time Frame: From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 24 months) ]
    DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression,as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurred first. DOR was evaluated for participants who had a objective response of CR or PR.

  4. Proportion of Participants who Report a Clinically Meaningful Improvement in Patient-Reported Abdominal Pain or Bloating [ Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) ]
    A clinically meaningful improvement in patient-reported abdominal pain or bloating was defined as a ≥10-point decrease from the linearly transformed 0-100 point baseline symptom scale score on each of two items from the Abdominal/Gastrointestinal Symptom Scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28).

  5. Proportion of Participants who Report a Clinically Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) [ Time Frame: From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 24 months) ]
    A clinically meaningful improvement in patient-reported function and HRQoL was defined as a >10-point increase from the linearly transformed 0-100 point baseline scale score on each of the four functional (physical, role, emotional, social) scales and global health status/HRQoL scale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30).

  6. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 76 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Life expectancy of at least 12 weeks.
  • Adequate hematological, liver, renal and neurologic functions.
  • For participants who receive therapeutic anticoagulation: stable anticoagulant regimen.
  • Enrollment between 1 and 12 weeks after initial surgery is performed for the combined purpose of diagnosis, staging, and cytoreduction

Exclusion Criteria:

  • Current diagnosis of borderline epithelial ovarian tumor or recurrent invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer treated with surgery only.
  • Prior radiotherapy to any portion of the abdominal cavity or pelvis.
  • Prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant chemotherapy for ovarian, primary peritoneal, or fallopian tube cancer.
  • Any prior targeted therapy (including, but not limited to, vaccines, antibodies, or tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian or peritoneal primary cancer.
  • Synchronous primary endometrial cancer.
  • Have a prior history of primary endometrial cancer, except: Stage not greater than Stage IB; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions.
  • Cancer present within the last 5 years with the exception of non-melanoma-related skin cancers and other specific malignancies or whose previous cancer treatment contraindicates study treatment.
  • Active hepatitis B virus (HBV) infection (chronic or acute) or active hepatitis C virus (HCV) infection.
  • Serious non-healing wounds, ulcers, or bone fractures.
  • Patients with clinically significant cardiovascular disease.
  • Have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
  • Have known sensitivity to any component of paclitaxel.
  • Undergo major surgical procedure within 28 days prior to randomization or anticipated during the course of the study.
  • Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab/placebo.
  • History or evidence of thrombotic disorders within the last 6 months prior to enrollment.

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): NCT03635489


Locations
Show Show 17 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03635489    
Other Study ID Numbers: YO40268
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors