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A Phase III Trial of Cisplatin plus Paclitaxel with and without Bevacizumab versus Topotecan plus Paclitaxel, with and without Bevacizumab, in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix
[Protocol 09-098]
- Full 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 (GOG 0240)
- Purpose :
Chemotherapy with cisplatin and paclitaxel is the standard treatment for cancer of the cervix which is not curable by surgery or radiation therapy. In addition to studying cisplatin plus paclitaxel, other combinations of drugs (such as topotecan plus paclitaxel) and newer drugs (such as bevacizumab) need to be studied in patients with this disease. Topotecan and bevacizumab have both shown promise for treating cervical cancer.
The purpose of this phase III Gynecologic Oncology Group clinical trial is to compare the effectiveness of four different combinations of anticancer drugs in women with stage IVB, recurrent, or persistent cervical cancer. Patients will be randomly assigned to receive one of the following regimens:
- cisplatin plus paclitaxel
- cisplatin, paclitaxel, and bevacizumab
- paclitaxel plus topotecan
- paclitaxel, topotecan, and bevacizumab
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have primary stage IVB, recurrent, or persistent squamous cell
carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which
cannot be cured with surgery and/or radiation therapy.
- Patients must have recovered from the side effects of prior therapies. At least 6 weeks must have passed since chemoradiotherapy or major surgery and 3 weeks since radiation therapy alone and entry into the study.
- Patients may not have previously received bevacizumab or any other VEGF inhibitors.
For more information and to inquire about eligibility for this study, please contact Dr. Mario Leitao at 212-639-3987.
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