Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (RADBEV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Pittsburgh
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Genentech
Information provided by (Responsible Party):
Robert Edwards, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01031381
First received: December 10, 2009
Last updated: March 13, 2013
Last verified: March 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • everolimus
  • derivative of rapamycin
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
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

Contacts
Contact: Vicki Gilchrist, RN 412.641.6373 gilchristvb@upmc.edu
Contact: Robert Edwards, MD 412-641-5418 redwards@mail.magee.edu

Locations
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         
Sponsors and Collaborators
University of Pittsburgh
Novartis Pharmaceuticals
Genentech
Investigators
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
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Abdominal Neoplasms
Digestive System Neoplasms
Sirolimus
Everolimus
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Digestive System Diseases
Peritoneal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 30, 2014