Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (RADBEV)
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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 Cancer |
Drug: RAD001 Drug: bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- To evaluate the progression-free survival at 6 months for RAD001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: Yes ]
- To evaluate the efficacy (complete response + partial response + stable disease) of RAD001 and bevacizumab in recurrent ovarian, peritoneal, and fallopian tube cancer [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Rad001/Bevacizumab
Patients will recieve 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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| Contact: Vicki Gilchrist, RN | 412.641.6373 | gilchristvb@upmc.edu |
| Contact: Robert Edwards, MD | 412-641-5418 | redwards@mail.magee.edu |
| United States, Pennsylvania | |
| Magee-Womens Hospital of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Vicki Gilchrist, RN, BSN 412-641-6373 gilchristvb@upmc.edu | |
| Contact: Kristin Zorn, MD 412-641-5468 kzorn@magee.edu | |
| Principal Investigator: Robert Edwards, MD | |
| Sub-Investigator: Thomas Krivak, MD | |
| Sub-Investigator: Kristin Zorn, MD | |
| Sub-Investigator: Paniti Sukumvanich, MD | |
| Sub-Investigator: Joseph Kelley, MD | |
| Sub-Investigator: Alexander Olawaiye, MD | |
| Sub-Investigator: John Comerci, MD | |
| Principal Investigator: | Robert Edwards, MD | University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division |
More Information
No publications provided
| 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 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
Recurrent ovarian fallopian tube |
primary peritoneal cancer Recurrent ovarian, fallopian tube, primary peritoneal cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Abdominal Neoplasms Digestive System Neoplasms Everolimus Sirolimus Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Endocrine System Diseases Gonadal Disorders Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Bevacizumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013