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Phase II Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Carcinoma, Primary Peritoneal Carcinoma

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Trial Information

Phase II Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary


Patients will be treated with pemetrexed 500 mg/m2 IV and Bevacizumab 15 mg/kg IV every 3
weeks.The patient is treated indefinitely until side effects are deemed severe by the
investigator or until progression. Disease progression is measured every 6 weeks using
RECIST criteria.


Inclusion Criteria:



- Recurrent epithelial ovarian or primary peritoneal carcinoma

- Measurable disease

- At lease 1 target lesion to assess response by RECIST

- GOG performance status 0 or 1

- Recovery from effects of recent surgery, radiotherapy or chemotherapy, must
discontinue hormonal therapy

- Must have had 1 prior platinum based chemotherapeutic regimen for management of
primary disease

- Must have had 1 prior regimen containing a taxane compound

Exclusion Criteria:

- Prior therapy with pemetrexed or bevacizumab

- Serious, non-healing wound, ulcer or bone fracture

- Clinically significant cardiovascular disease

- Active bleeding or pathogenic conditions that carry high risk of bleeding, such as
known bleeding disorder, coagulopathy, or tumor involving major - vessels

- Ascites or other third space fluid which cannot be controlled by drainage

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to day 1 or anticipation of need for major surgical procedure during course of
study

- History or evidence upon physical exam of CNS disease, including primary brain tumor,
brain mets, seizure not controlled with standard medical therapy, history of
CVA/stroke/TIA, or subarachnoid hemorrhage within 6 mos. of day 1

- Proteinuria

- History of abdominal fistula, GI perforation or intra-abdominal abscess within 6 mo.

- Partial or complete small or large bowel obstruction within 3 mo.

- Life expectancy less than 12 weeks

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the anti-tumor activity of the combination of bevacizumab and pemetrexed as measured by progression-free survival in patients with recurrent epithelial ovarian or primary peritoneal carcinoma

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

David G Mutch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

08-0508 / 201102272

NCT ID:

NCT00868192

Start Date:

June 2008

Completion Date:

December 2012

Related Keywords:

  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Columbia UniversityNew York, New York  10032-3784
Washington UniversitySt. Louis, Missouri  63110