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

Primary Peritoneal Cavity Cancer Clinical Trial

Official title:

A Phase II Evaluation of Bevacizumab (Anti-VEGF Humanized Monoclonal Antibody) (NSC #704865) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022659
• Other study ID #: NCI-2012-02400
• Secondary ID: NCI-2012-02400CD
• Status: Completed
• Phase: Phase 2
• Start date: April 2002
• Est. completion date: March 2010

Study information

• Verified date: July 2019
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

Description:

PRIMARY OBJECTIVES:

I. Determine the 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab.

II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug.

IV. Determine the frequency of clinical response in patients treated with this drug.

V. Determine the effect of this drug on initial performance status, age, and mucinous or clear cell histology in these patients.

VI. Correlate biological and imaging markers with 6-month progression-free survival of patients treated with this drug.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Gynecologic Oncology Group (GOG) protocols (i.e., active phase III GOG protocols for the same patient population)

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

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

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• No known bleeding disorder or coagulopathy

• No active bleeding

• Bilirubin = 1.5 times upper limit of normal (ULN)

• serum glutamate oxaloacetate transaminase (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)

• Partial thromboplastin time (PTT) < 1.2 times control

• Creatinine = 1.5 times ULN

• 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

• 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

• 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

• At least 3 weeks since prior immunologic therapy directed at malignancy

• No prior bevacizumab

• No other concurrent immunotherapy directed at malignancy

• 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

• At least 1 week since prior hormonal therapy directed at malignancy

• No concurrent hormonal therapy directed at malignancy

• Concurrent hormone replacement therapy allowed

• Recovered from prior radiotherapy

• No concurrent radiotherapy directed at malignancy

• 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

• At least 3 weeks since other prior therapy directed at malignancy

• No prior anticancer therapy that would preclude study entry

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Primary Peritoneal Cavity Cancer
• Recurrent Ovarian Epithelial Cancer
• Stage IV Ovarian Epithelial Cancer

Intervention

Biological:
• bevacizumab
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival at 6 Months	Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.	Every other cycle for 6 months.
Primary	Tumor Response	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.	Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months thereafter for up to 5 years.
Primary	Number of Participants and Degree of Toxicity of Bevacizumab in This Cohort of Patients as Assessed by CTC.		Assessed every cycle while on treatment, 30 days after the last cycle of treatment, up to 5 years.
Secondary	Overall Survival	The observed length of life from entry into the study to death or the date of last contact.	From study entry to death or last contact, up to 5 years.
Secondary	Duration of Progression-free Survival	Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.	Every other cycle for the first 6 months; then every 3 months x 2 ; then every 6 months therafter for up to 5 years.