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Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (RADBEV)
This study has been completed.
Sponsor:
University of Pittsburgh
Collaborators:
Novartis Pharmaceuticals
Genentech, Inc.
Information provided by (Responsible Party):
Robert Edwards, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01031381
First received: December 10, 2009
Last updated: July 19, 2016
Last verified: January 2016
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Purpose
This study will investigate the efficacy as well as the safety of RAD001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be taken orally once daily and bevacizumab will be administered once every 14 days. The study will be conducted over a period of about 3 to 4 years.
| Condition | Intervention | Phase |
|---|---|---|
| Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma | Drug: RAD001 Drug: bevacizumab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Phase II Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer An Investigator-initiated, Single-institution Trial at Magee-Womens Hospital |
Resource links provided by NLM:
Genetics Home Reference related topics:
ovarian cancer
MedlinePlus related topics:
Health Facilities
U.S. FDA Resources
Further study details as provided by Robert Edwards, University of Pittsburgh:
Primary Outcome Measures:
- Progression-free Survival (PFS) at 6-months [ Time Frame: Up to 36 months (data collection period for the cohort); Up to 6 months for participant ]The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Secondary Outcome Measures:
- Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) [ Time Frame: Within 4 weeks (28 days) of study treatment initiation (baseline) ]The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
| Enrollment: | 50 |
| Study Start Date: | September 2010 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Rad001/Bevacizumab
Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression.
|
Drug: RAD001
RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal.
Other Names:
Drug: bevacizumab
bevacizumab will be administered intravenously (IV) once every 14 days.
Other Name: Avastin
|
Detailed Description:
In this trial, approximately 50 patients will receive the study drug, RAD001 in combination with bevacizumab (Avastin)chemotherapy. RAD001 will be taken orally once daily and bevacizumab will be administered intravenously once every 14 days. In addition to study treatment, a few blood samples and a sample of the patients tumor from a previous surgery if available will be collected for research.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients may or may not have measurable disease. Measurable disease is defined according to RECIST criteria. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation was completed.
- Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy)
- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN.
- Performance status £ 2
- Signed informed consent.
Exclusion Criteria:
- Prior treatment with any investigational drug within the preceding 4 weeks
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
- Uncontrolled brain or leptomeningeal metastases
- Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation
- Uncontrolled diabetes mellitus
- A known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease
- Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
- Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control.
- Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
- Patients with a known hypersensitivity to RAD001 (everolimus), other rapamycins (sirolimus, temsirolimus) or excipients, or bevacizumab
- Patients with serious non-healing wound, ulcer, or bone fracture.
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031381
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031381
Locations
| United States, Pennsylvania | |
| Magee-Womens Hospital of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
Sponsors and Collaborators
University of Pittsburgh
Novartis Pharmaceuticals
Genentech, Inc.
Investigators
| Principal Investigator: | Robert Edwards, MD | University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division |
More Information
| Responsible Party: | Robert Edwards, Principal Investigator, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01031381 History of Changes |
| Other Study ID Numbers: |
09-01-RAD001BEV |
| Study First Received: | December 10, 2009 |
| Results First Received: | January 31, 2016 |
| Last Updated: | July 19, 2016 |
Keywords provided by Robert Edwards, University of Pittsburgh:
|
Recurrent ovarian fallopian tube |
primary peritoneal cancer Recurrent ovarian, fallopian tube, primary peritoneal cancer |
Additional relevant MeSH terms:
|
Fallopian Tube Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Bevacizumab Everolimus Sirolimus Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |
ClinicalTrials.gov processed this record on August 18, 2017