Gynecologic Cancer Treatment Trials
Research Study of Collection of Gynecological Tumor Specimens (GOG 0136)
Purpose
Collecting and storing samples of tumor tissue from patients with cancerto study in the laboratory may help in the study of cancer.
This laboratory study is collecting tumor tissue samples from patients with gynecologictumors.
Eligibility
Eligibility criteria include the following:
- Had previous surgery for ovarian cancer, cervical cancer, uterine cancer, or peritoneal cancer or had ovaries removed because of family history of cancer
- No more than 6 weeks since surgery
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention
Tumor tissue removed from the patient during surgery will be collected and kept for future use in studying cancer.
Phase III Randomized Study of Adjuvant Chemoradiotherapy Comprising Cisplatin and Tumor Volume-Directed Radiotherapy Followed by Carboplatin and Paclitaxel Versus Carboplatin and Paclitaxel Alone in Patients With Stage III or IVA Endometrial Carcinoma (GOG 0258)
Purpose
Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.
This randomized phase III trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage III or stage IVA endometrial cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Has undergone surgery to remove the uterus, both ovaries, and both fallopian tubes within the past 8 weeks
- No carcinosarcoma or recurrent endometrial cancer
- No previous radiation therapy to the pelvis or abdomen
- No previous chemotherapy for endometrial cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will receive an infusion of cisplatin in weeks 1 and 4. They will also undergo external-beam radiation therapy 5 days a week for up to 6 weeks. Some patients may then undergo implant radiation over 2-3 weeks. Beginning no more than 8 weeks later, patients will receive a 3-hour infusion of paclitaxel and an infusion of carboplatin every 3 weeks for up to four courses.
- Patients in group two will receive a 3-hour infusion of paclitaxel and an infusion of carboplatin. Treatment may repeat every 3 weeks for up to six courses.
Patients will fill out quality-of-life questionnaires periodically.
After finishing treatment, patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.
Phase III Randomized Study of Bevacizumab in Combination With Intravenous Versus Intraperitoneal Chemotherapy in Patients With Stage II or III Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Carcinoma (GOG 0252)
Purpose
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. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bevacizumab together with intravenous chemotherapy is more effective than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
This randomized phase III trial is studying bevacizumab and intravenous chemotherapy to see how well they work compared with bevacizumab and intraperitoneal chemotherapy in treating patients with stage II or stage III ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No more than 12 weeks since surgery
- No primary brain tumor or brain metastases
- No previous radiation therapy to the abdomen or pelvis
- No previous chemotherapy for any tumor in the abdomen or pelvis
- No previous vaccines, antibodies, tyrosine kinase inhibitors, or hormone therapy for ovarian epithelial cancer or primary peritoneal cancer
- No previous bevacizumab
- More than 4 weeks since surgery or open biopsy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of three treatment groups.
- Patients in group one will receive a 1-hour infusion of paclitaxel once a week for 3 weeks and an infusion of carboplatin in week 1. Beginning with course two, they will also receive a 30- to 90-minute infusion of bevacizumab in week 1. Treatment may repeat every 3 weeks for up to six courses. Patients will then receive bevacizumab alone for up to 16 courses.
- Patients in group two will receive a 1-hour infusion of paclitaxel once a week for 3 weeks and an intraperitoneal infusion of carboplatin in week 1. Beginning with course two, they will also receive a 30- to 90-minute infusion of bevacizumab in week 1. Treatment may repeat every 3 weeks for up to six courses. Patients will then receive bevacizumab alone for up to 16 courses.
Patients in group three will receive a 3-hour infusion of paclitaxel and an intraperitoneal infusion of cisplatin in week 1 and an intraperitoneal infusion of paclitaxel in week 2. Beginning with course two, they will also receive a 30- to 90-minute infusion of bevacizumab in week 1. Treatment may repeat every 3 weeks for up to six courses. Patients will then receive bevacizumab alone for up to 16 courses.
Patients will fill out quality-of-life questionnaires at the beginning of the study and periodically thereafter. They may also undergo blood and tissue sample collection for laboratory studies.
After finishing treatment, patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once a year for 5 years.
Phase III Randomized Study of Paclitaxel in Combination With Cisplatin or Topotecan Hydrochloride With or Without Bevacizumab in Patients With Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix (GOG 0240)
Purpose
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.
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.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Measurable disease
- No primary brain tumor, brain metastases, or spinal cord metastases
- No previous bevacizumab
- At least 6 weeks since chemotherapy with radiation therapy
- At least 3 weeks since radiation therapy
- More than 4 weeks since surgery or open biopsy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of four treatment groups.
- Patients in group one will receive a 3-hour infusion of paclitaxel or a 1-day continuous infusion of paclitaxel on day 1. They will also receive an infusion of cisplatin on day 1 or 2.
- Patients in group two will receive a 3-hour infusion of paclitaxel or a 1-day continuous infusion of paclitaxel on day 1. They will also receive an infusion of cisplatin and a 30- to 90-minute infusion of bevacizumab on day 1 or 2.
- Patients in group three will receive a 3-hour infusion of paclitaxel on day 1. They will also receive an infusion of topotecan on days 1-3.
- Patients in group four will receive a 3-hour infusion of paclitaxel and a 30- to 90-minute infusion of bevacizumab on day 1. They will also receive an infusion of topotecan on days 1-3.
In all groups, treatment may repeat every 3 weeks for as long as benefit is shown.
Patients will fill out quality-of-life questionnaires periodically. They will also fill out a smoking questionnaire at the beginning of the study.
After finishing treatment, patients will be evaluated every 3 months for 2 years and every 6 months for 3 years.
Phase II Randomized Study of Pelvic Radiotherapy With Versus Without Cisplatin in Patients With Recurrent Endometrial Cancer (GOG 0238)
Purpose
Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.
This randomized phase II trial is studying radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with recurrent endometrial cancer.
Eligibility
Eligibility criteria include the following:
- Has undergone surgery to remove the uterus, cervix, both ovaries, and both fallopian tubes
- Cancer has not spread outside of the pelvis
- At least 6 months since hormone therapy and/or chemotherapy
- No previous radiation therapy to the vagina, pelvis, or abdomen
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will undergo external-beam radiation therapy to the pelvis 5 days a week for 6 weeks. They will then undergo internal radiation therapy.
- Patients in group two will undergo external-beam radiation therapy to the pelvis 5 days a week for 6 weeks. They will also receive a 1- to 2-hour infusion of cisplatin once a week for 6 weeks. Patients will then undergo internal radiation therapy.
After finishing treatment, patients will be evaluated once a month for 3 months, every 3 months for 2 years, and every 6 months for 3 years.
Phase III Randomized Study of Adjuvant Chemotherapy Comprising Carboplatin and Paclitaxel With Versus Without Bevacizumab and/or Secondary Cytoreduction Surgery in Patients With Platinum-Sensitive Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (GOG 0213)
Purpose
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 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 combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
This randomized phase III trial is studying giving carboplatin and paclitaxel together with or without bevacizumab after surgery to see how well it works in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Complete response to previous front-line chemotherapy
- At least six months since bevacizumab
- No previous radiation therapy to the abdomen or pelvis
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients may undergo surgery to remove the tumor and collect tumor tissue samples. They will also fill out quality of life questionnaires before and after surgery. All patients will then be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will receive a 3-hour infusion of paclitaxel or a 1-hour infusion of docetaxel on day 1. They will also receive an infusion of carboplatin on day 1. Treatment may repeat every 3 weeks for up to eight courses.
- Patients in group two will receive a 3-hour infusion of paclitaxel or a 1-hour infusion of docetaxel on day 1. They will also receive an infusion of carboplatin and a 30- to 90-minute infusion of bevacizumab on day 1. Treatment may repeat every 3 weeks for up to eight courses. Patients will then receive a 30- to 90-minute infusion of bevacizumab every 3 weeks for as long as benefit is shown.
After finishing treatment, patients will be evaluated periodically for 10 years.
Study to Collect Clinical Specimens For Molecular Staging of Endometrial Carcinoma (GOG 0210)
Purpose
Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of cancer.
The purpose of this study is to collect and store tissue, blood, and other body fluid samples from patients with endometrial cancer to be tested in the laboratory. This study also is finding out if analysis of tumor tissue will help predict the recurrence of cancer.
Eligibility
Eligibility criteria include the following:
- Able to undergo surgery
- No previous chemotherapy for cancer
- No previous radiation therapy to the pelvis or abdomen
No previous retroperitoneal surgery
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention
Patients will undergo hysterectomy, surgery to remove the ovaries, lymph node dissection, or a biopsy of endometrial tissue. Special Testing will be performed on tissue, blood, and other body fluid samples collected from patients during surgery, six weeks after surgery, and three years after surgery. Patients will also be asked to complete a questionnaire about their cancer.
Research Study of Collection of Gynecological Tumor Specimens (GOG 0136)
Purpose
Collecting and storing samples of tumor tissue from patients with cancer to study in the laboratory may help in the study of cancer.
This laboratory study is collecting tumor tissue samples from patients with gynecologic tumors.
Eligibility
Eligibility criteria include the following:
- Had previous surgery for ovarian cancer, cervical cancer, uterine cancer, or peritoneal cancer or had ovaries removed because of family history of cancer
- No more than six weeks since surgery
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention
Tumor tissue removed from the patient during surgery will be collected and kept for future use in studying cancer.