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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00483782 |
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.
Condition | Intervention | Phase |
---|---|---|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: bevacizumab Drug: carboplatin Drug: paclitaxel Procedure: quality-of-life assessment Procedure: questionnaire administration Procedure: study of socioeconomic and demographic variables |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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 |
Estimated Enrollment: | 1520 |
Study Start Date: | April 2006 |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
Meets 1 of the following staging criteria:
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:
Synchronous primary endometrial carcinoma or a past history of primary endometrial carcinoma allowed provided the following criteria are met:
No history or clinical suspicion of brain metastases or spinal cord compression
PATIENT CHARACTERISTICS:
No nonhealing wound, ulcer, or bone fracture
No clinically significant cardiovascular disease, including any of the following:
Poorly controlled cardiac arrhythmia despite medication
PRIOR CONCURRENT THERAPY:
More than 10 days since prior and no concurrent chronic use of acetylsalicylic acid (> 325 mg/day)
More than 10 days since prior and no concurrent full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
Study Chair: | Tim J. Perren, MD | Leeds Cancer Centre at St. James's University Hospital |
Study ID Numbers: | CDR0000548777, MREC-ICON7, EUDRACT-2005-003929-22, ISRCTN91273375, ROCHE-MREC-ICON7, EU-20730, MREC-06/MRE02/52 |
Study First Received: | June 6, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00483782 |
Health Authority: | Unspecified |
fallopian tube cancer peritoneal cavity cancer stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer Brenner tumor |
ovarian carcinosarcoma ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma |
Cystadenocarcinoma, Serous Tooth Diseases Gonadal Disorders Urogenital Neoplasms Bevacizumab Ovarian Diseases Ovarian epithelial cancer Carcinoma, Endometrioid Dental Caries Genital Diseases, Female Ovarian carcinosarcoma Peritoneal Diseases Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms |
Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Carboplatin Abdominal Neoplasms Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Digestive System Diseases Paclitaxel Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Stomatognathic Diseases Peritoneal Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors Tooth Demineralization Pharmacologic Actions |
Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |