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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00803062 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by 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. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer.
PURPOSE: This randomized phase III trial is studying the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, recurrent, or persistent cervical cancer.
Condition | Intervention | Phase |
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Cervical Cancer |
Biological: bevacizumab Drug: cisplatin Drug: paclitaxel Drug: topotecan hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC #704865, IND #7921) Versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied Bevacizumab, In Stage IVB, Recurrent or Persistent Carcinoma of the Cervix |
Estimated Enrollment: | 450 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV on day 1 or 2.
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Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
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Arm II: Experimental
Patients receive paclitaxel IV over 3 hours or 24 hours on day 1 and cisplatin IV and bevacizumab IV over 30-90 minutes on day 1 or 2.
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Biological: bevacizumab
Given IV
Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
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Arm III: Experimental
Patients receive paclitaxel IV over 3 hours on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
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Drug: paclitaxel
Given IV
Drug: topotecan hydrochloride
Given IV
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Arm IV: Experimental
Patients receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1 and topotecan hydrochloride IV over 30 minutes on days 1-3.
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Biological: bevacizumab
Given IV
Drug: paclitaxel
Given IV
Drug: topotecan hydrochloride
Given IV
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to disease status (recurrent/persistent disease vs primary stage IVB disease), GOG performance status (0 vs 1), and prior platinum therapy as a radiosensitizer (yes vs no). Patients are randomized to 1 of 4 treatment arms.
Patients complete quality-of-life questionnaires, including the FACT-Cx TOI, FACT/GOG-Ntx4, and Brief Pain Inventory, at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. Patients also complete a smoking questionnaire at baseline.
After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the cervix, including any of the following subtypes:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Has ≥ 1 "target lesion" that can be used to assess response
PATIENT CHARACTERISTICS:
No serious non-healing wound, ulcer, or bone fracture
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 3-6 months
No clinically significant cardiovascular disease, including any of the following:
Serious cardiac arrhythmia requiring medication
PRIOR CONCURRENT THERAPY:
United States, Indiana | |
St. Vincent Indianapolis Hospital | Recruiting |
Indianapolis, Indiana, United States, 46260 | |
Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
United States, Michigan | |
Borgess Medical Center | Recruiting |
Kalamazoo, Michigan, United States, 49001 | |
Contact: Raymond S. Lord, MD 269-373-7458 | |
Bronson Methodist Hospital | Recruiting |
Kalamazoo, Michigan, United States, 49007 | |
Contact: Raymond S. Lord, MD 269-373-7458 | |
West Michigan Cancer Center | Recruiting |
Kalamazoo, Michigan, United States, 49007-3731 | |
Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |
United States, Oklahoma | |
Cancer Care Associates - Saint Francis Campus | Recruiting |
Tulsa, Oklahoma, United States, 74136-1929 | |
Contact: Robert S. Mannel, MD 405-271-8787 | |
Oklahoma University Cancer Institute | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Robert S. Mannel, MD 405-271-8787 | |
United States, Pennsylvania | |
Rosenfeld Cancer Center at Abington Memorial Hospital | Recruiting |
Abington, Pennsylvania, United States, 19001 | |
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M 215-481-2402 | |
United States, Rhode Island | |
Women and Infants Hospital of Rhode Island | Recruiting |
Providence, Rhode Island, United States, 02905 | |
Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122 |
Principal Investigator: | Krishnansu Tewari, MD | Chao Family Comprehensive Cancer Center |
Responsible Party: | Gynecologic Oncology Group ( Philip J. DiSaia ) |
Study ID Numbers: | CDR0000628746, GOG-0240 |
Study First Received: | December 4, 2008 |
Last Updated: | April 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00803062 History of Changes |
Health Authority: | Unspecified |
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma recurrent cervical cancer stage IVB cervical cancer |
Antimitotic Agents Bevacizumab Squamous Cell Carcinoma Angiogenesis Inhibitors Recurrence Carcinoma Cisplatin Radiation-Sensitizing Agents |
Paclitaxel Epidermoid Carcinoma Tubulin Modulators Carcinoma, Squamous Cell Adenocarcinoma Topotecan Antineoplastic Agents, Phytogenic Carcinoma, Adenosquamous |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Enzyme Inhibitors Bevacizumab Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions |
Cisplatin Radiation-Sensitizing Agents Paclitaxel Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Topotecan Antineoplastic Agents, Phytogenic |