Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003646

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or stopping them from
dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether
giving carboplatin and paclitaxel together with bevacizumab is more effective than
carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer,
fallopian tube cancer, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and
bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in
treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or
primary peritoneal cavity cancer.

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Brief Summary in Scientific Language

OBJECTIVES:

Primary

- 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

- Compare the response rate in patients treated with these regimens.

- Compare the duration of tumor response in patients treated with these regimens.

- Compare the biological progression-free interval, as measured by increasing CA 125
levels, in patients treated with these regimens.

- Compare the safety (e.g., adverse events, laboratory results, and performance status)
of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

- Compare the cost-effectiveness of these regimens in these patients.

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.

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Organizational Data

  •   DRKS00003646
  •   2012/05/08
  •   2007/06/06
  •   yes
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Secondary IDs

  •   2005-003929-22 
  •   NCT00483782  (ClinicalTrials.gov)
  •   MREC-ICON7  (Medical Research Council)
  •   EUDRACT-2005-003929-22 
  •   ISRCTN91273375 
  •   ROCHE-MREC-ICON7 
  •   EU-20730 
  •   MREC-06/MRE02/52 
  •   CDR0000548777 
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Health Condition or Problem studied

  •   Fallopian Tube Cancer
  •   Ovarian Cancer
  •   Primary Peritoneal Cavity Cancer
  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Biological: bevacizumab
  •   Drug: carboplatin
  •   Drug: paclitaxel
  •   Other: questionnaire administration
  •   Other: study of socioeconomic and demographic variables
  •   Procedure: quality-of-life assessment
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
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  •   III
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Primary Outcome

- Progression-free survival

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Australia
  •   France
  •   Germany
  •   Norway
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2006/04/30
  •   1520
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion 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

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 12 weeks

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- 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

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)

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Exclusion Criteria

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Addresses

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    • Medical Research Council
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    • Leeds Cancer Centre at St. James's University Hospital
    • Tim J. Perren, MD 
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    • Leeds Cancer Centre at St. James's University Hospital
    • Tim J. Perren, MD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
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Trial Publications, Results and other Documents

  •   Clinical trial summary from the National Cancer Institute's PDQ® database
  •   Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stähle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM; ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96.; 22204725
  •   Dhillon S. Bevacizumab Combination Therapy: For the First-Line Treatment of Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer. Drugs. 2012 Apr 19. doi: 10.2165/11208940-000000000-00000. [Epub ahead of print] PubMed PMID: 22515620.; 22515620
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.