Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	GOG-0170D NCT00022659

Objectives

1. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab.
2. Determine the nature and degree of toxicity of this drug in these patients.
3. Determine the progression-free and overall survival of patients treated with this drug.
4. Determine the frequency of clinical response in patients treated with this drug.
5. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients.
6. Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
  • Recurrent or persistent after initial standard surgery or chemotherapy
  • Incurable with standard surgery, chemotherapy, or radiotherapy



• At least 1 unidimensionally measurable target lesion
  • At least 20 mm by conventional techniques
  • At least 10 mm by spiral CT scan
  • Outside the area of prior radiotherapy

• Accessible to guided core needle biopsy

• Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease
  • May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Patients with only 1 prior platinum-based chemotherapy regimen must have an initial treatment-free interval of less than 12 months
  • Patients with an initial treatment-free interval of more than 12 months must have progressive disease after prior platinum-based chemotherapy regimen as second-line therapy



• No tumors involving major blood vessels



• No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5 years



• Ineligible for higher priority GOG protocols (i.e., active phase III GOG protocols for the same patient population)

Prior/Concurrent Therapy:

Biologic therapy:

• At least 3 weeks since prior immunologic therapy directed at malignancy
• No prior bevacizumab
• No other concurrent immunotherapy directed at malignancy

Chemotherapy:

• See Disease Characteristics
• One additional prior cytotoxic regimen for recurrent or persistent disease allowed
• No prior non-cytotoxic chemotherapy for recurrent or persistent disease
• No concurrent chemotherapy directed at malignancy

Endocrine therapy:

• At least 1 week since prior hormonal therapy directed at malignancy
• No concurrent hormonal therapy directed at malignancy
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• Recovered from prior radiotherapy
• No concurrent radiotherapy directed at malignancy

Surgery:

• See Disease Characteristics
• At least 28 days since prior major surgery or open biopsy and recovered
• At least 7 days since prior core biopsy or placement of vascular access device
• No anticipated need for major surgical procedure during study participation

Other:

• At least 3 weeks since other prior therapy directed at malignancy
• No prior anticancer therapy that would preclude study entry

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-2 (patients who have received 1 prior regimen)
• GOG 0-1 (patients who have received 2 prior regimens)

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• No known bleeding disorder or coagulopathy
• No active bleeding

Hepatic:

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular weight heparin)
• PTT < 1.2 times control

Renal:

• Creatinine ≤ 1.5 times ULN

  OR

• Creatinine clearance > 60 mL/min
• No proteinuria, as indicated by 1 of the following:
  • Negative urine dipstick
  • Urine protein < 30 mg/dL
  • Urine protein < 1,000 mg on 24-hour urine collection

Cardiovascular:

• No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension
  • Myocardial infarction within the past 6 months
  • Unstable angina within the past 6 months
  • New York Heart Association class II-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Peripheral vascular disease ≥ grade 2
• No stroke within the past 5 years

Other:

• No pathologic condition that carries a high risk of bleeding
• No significant traumatic injury within the past 28 days
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No uncontrolled seizures within the past 5 years
• No neuropathy (motor and sensory) ≥ grade 2
• No serious non-healing wound, ulcer, or bone fracture
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
• No active infection requiring parenteral antibiotics
• No known claustrophobia that would preclude MRI tolerance
• No ferromagnetic implants or pacers
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study treatment

Expected Enrollment

A total of 55-62 patients will be accrued for this study within 2.2-2.5 years.

Outline

This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Han ES, Burger R, Darcy KM, et al.: Relationship between angiogenic markers and clinicopathologic factors/outcome in GOG-170D, a phase II trial of bevacizumab (Bev) in recurrent or persistent epithelial ovarian cancer (EOC) and primary peritoneal cancer (PPC). [Abstract] J Clin Oncol 26 (Suppl 15): A-5577, 2008.

Burger RA, Sill MW, Monk BJ, et al.: Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25 (33): 5165-71, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Robert Burger, MD, Protocol chair		Ph: 714-456-7971 Email: raburger@uci.edu

Registry Information
Official Title		A Phase II Evaluation Of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865, IND #7921) In The Treatment of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma
Trial Start Date		2002-04-29
Registered in ClinicalTrials.gov		NCT00022659
Date Submitted to PDQ		2001-06-28
Information Last Verified		2004-09-09
NCI Grant/Contract Number		CA27469