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Clinical Trials (PDQ®)

  • First Published: 6/4/2007
  • Last Modified: 4/30/2012

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Phase III Randomized Study of Carboplatin and Paclitaxel With Versus Without Bevacizumab in Patients With Newly Diagnosed Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentUnknown18 and overOther, Pharmaceutical / IndustryMREC-ICON7
EUDRACT-2005-003929-22, ISRCTN91273375, ROCHE-MREC-ICON7, EU-20730, ICON7, MREC-06/MRE02/52, NCT00483782

Objectives

Primary

  1. Compare the progression-free survival and overall survival of patients with newly diagnosed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with carboplatin and paclitaxel with vs without bevacizumab.

Secondary

  1. Compare the response rate in patients treated with these regimens.
  2. Compare the duration of tumor response in patients treated with these regimens.
  3. Compare the biological progression-free interval, as measured by increasing CA 125 levels, in patients treated with these regimens.
  4. Compare the safety (e.g., adverse events, laboratory results, and performance status) of these regimens in these patients.
  5. Compare the quality of life of patients treated with these regimens.
  6. Compare the cost-effectiveness of these regimens in these patients.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
    • Newly diagnosed disease

  • Meets 1 of the following staging criteria:
    • High-risk stage I or IIA disease (grade 3 disease or clear cell carcinoma only)
    • Stage IIB-IV disease (all grades and all histological types)

  • Must have undergone initial surgery (e.g., debulking cytoreductive surgery or a biopsy if the patient has stage IV disease) within the past 6 weeks
    • Patients with stage IV disease for which initial surgical debulking was not appropriate are eligible provided the following criteria are met:
      • Stage IV disease diagnosed by histology
      • No planned surgery prior to disease progression, including interval debulking surgery

  • Patients with prior early-stage ovarian epithelial or fallopian tube carcinoma treated with surgery alone are eligible at the time of diagnosis of abdominopelvic recurrence provided no further interval cytoreductive therapy is planned prior to disease progression

  • Synchronous primary endometrial carcinoma or a past history of primary endometrial carcinoma allowed provided the following criteria are met:
    • Disease ≤ stage IB
    • No more than superficial myometrial invasion
    • No lymphovascular invasion
    • Not poorly differentiated (i.e., no grade 3, papillary serous, or clear cell disease)

  • Measurable or nonmeasurable disease

  • No ovarian nonepithelial cancer, including malignant mixed Müllerian tumors

  • No borderline tumors (e.g., tumors of low malignant potential)

  • No history or clinical suspicion of brain metastases or spinal cord compression
    • CT scan or MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases
    • Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • More than 4 weeks since other prior surgery or open biopsy
  • No prior systemic therapy for ovarian cancer (e.g., chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, or hormonal therapy)
  • Prior adjuvant chemotherapy allowed for other malignancies (e.g., breast or colorectal carcinoma) if malignancy was diagnosed over 5 years ago with no evidence of subsequent recurrence
  • No prior mouse CA 125 antibody
  • No prior radiotherapy to the abdomen or pelvis
  • More than 10 days since prior and no concurrent chronic use of acetylsalicylic acid (> 325 mg/day)
    • Low-dose (< 325 mg/day) acetylsalicylic acid allowed
  • More than 10 days since prior and no concurrent full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
    • Use of therapy for line patency allowed provided INR < 1.5
  • More than 30 days since prior and no other concurrent investigational agent or participation in another clinical trial
  • No other concurrent systemic antitumor agents
  • No concurrent surgery
  • No concurrent maintenance chemotherapy or intraperitoneal chemotherapy (including cytotoxic chemotherapy)

Patient Characteristics:

  • ECOG performance status 0-2
  • Life expectancy > 12 weeks
  • ANC ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9 g/dL (can be post-transfusion)
  • INR ≤ 1.5
  • APTT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • ALT and AST ≤ 2.5 times ULN
  • Creatinine ≤ 2.0 mg/dL
  • Proteinuria ≤ 1+ by urine dipstick OR ≤ 1 g by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 weeks after completion of study therapy
  • No significant traumatic injury within the past 4 weeks
  • No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
  • No other malignancies within the past 5 years except for adequately treated carcinoma in situ of the cervix, and/or basal cell skin cancer, and/or early endometrial carcinoma
  • No pre-existing sensory or motor neuropathy ≥ grade 2
  • No history or evidence of CNS disease (e.g., uncontrolled seizures) by neurological examination unless adequately treated with standard medical therapy
  • No history or evidence of thrombotic or hemorrhagic disorders
  • No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite antihypertensive therapy)
  • No known hypersensitivity to bevacizumab and its excipients, chemotherapy, or Cremophor EL
  • No nonhealing wound, ulcer, or bone fracture
    • Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require three weekly wound examinations
  • No clinically significant cardiovascular disease, including any of the following:
    • Myocardial infarction or unstable angina within the past 6 months
    • New York Heart Association class II-IV congestive heart failure
    • Poorly controlled cardiac arrhythmia despite medication
      • Rate-controlled atrial fibrillation allowed
    • Peripheral vascular disease ≥ grade 3 (i.e., symptomatic and interfering with activities of daily living requiring repair or revision)
  • No evidence of other disease or condition, metabolic dysfunction, physical examination findings, or laboratory findings that would contraindicate the use of an investigational drug or put the patient at high-risk for treatment-related complications

Expected Enrollment

1520

Outcomes

Primary Outcome(s)

Progression-free survival

Secondary Outcome(s)

Duration of overall survival
Objective response rate
Duration of response
Biological progression-free interval as measured by increasing CA 125 levels
Safety as measured by NCI CTAE version 3.0
Quality of life
Health economics

Outline

This is a multicenter, open-label, randomized, controlled study. Patients are stratified according to FIGO stage (stage I-III with residual disease ≤ 1 cm vs stage I-III with residual disease > 1 cm vs stage IV disease), intended time to start chemotherapy after surgery (≤ 4 weeks vs > 4 weeks), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (control): Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive bevacizumab IV over 30-90 minutes followed by paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then continue to receive bevacizumab alone every 3 weeks for 12 courses.

Quality of life is assessed at baseline, before every course, every 6 weeks for 1 year, every 3 months until disease progression or for up to 2 years, and then at 3 years. Health economic data is assessed periodically, including days of inpatient hospitalization visits, outpatient visits, and use of anticancer therapies.

After completion of study treatment, patients are followed every 3-6 months for 5 years and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Published Results

Perren TJ, Swart AM, Pfisterer J, et al.: A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med 365 (26): 2484-96, 2011.[PUBMED Abstract]

Related Publications

Dhillon S: Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Drugs 72 (7): 917-30, 2012.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Tim Perren, MD, Protocol chair
Ph: 44-113-206-4670
Email: t.j.perren@leeds.ac.uk

Registry Information
Official Title ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer
Trial Start Date 2006-04-09
Registered in ClinicalTrials.gov NCT00483782
Date Submitted to PDQ 2007-05-03
Information Last Verified 2012-04-30

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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