S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer
- Interventions
- Registration Number
- NCT00872989
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given alone or together with vandetanib.
PURPOSE: This randomized phase II trial is studying docetaxel given together with or without vandetanib to see how well it works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
- Detailed Description
OBJECTIVES:
* To evaluate the clinical efficacy of docetaxel and vandetanib relative to docetaxel alone in patients with platinum-resistant, recurrent, refractory, or progressive/persistent ovarian epithelial, primary peritoneal, or fallopian tube cancer, as measured by progression-free survival.
* To evaluate the response rate (complete and partial) and duration of overall survival of these patients.
* To evaluate the response (complete and partial) and time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel.
* To evaluate the frequency and severity of adverse events as assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.
* To evaluate the toxicity of single agent vandetanib following docetaxel as assessed by CTCAE v4.0.
OUTLINE: Patients are stratified according to prior treatment with antiangiogenesis agents (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
* Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I docetaxel Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity. Arm II vandetanib Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Arm II docetaxel Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Arm I vandetanib Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
- Secondary Outcome Measures
Name Time Method Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease Disease assessment for responses were performed every 6 weeks for as long as the patient remained on protocol treatment, up to 5 years. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses
Overall Survival every 3 months for two years and then every 6 months for 3 years From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Toxicity assessment was evaluated before each treatment cycle (21 days), up to 5 years. Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time to Treatment Failure Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years. Time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.
Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease After Treatment With Single Agent Vandetanib Following Progression on Single Agent Docetaxel Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses
Trial Locations
- Locations (137)
Providence Cancer Center at Providence Hospital
🇺🇸Mobile, Alabama, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
NEA Medical Center - Stadium Boulevard
🇺🇸Jonesboro, Arkansas, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
🇺🇸Burbank, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸Marysville, California, United States
Scroll for more (127 remaining)Providence Cancer Center at Providence Hospital🇺🇸Mobile, Alabama, United States