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Phase II Clinical Trial Of Bevacizumab (IND 7,921; NSC 704865) And Low Dose Oral Cyclophosphamide In Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

Phase 2
Not Enrolling
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

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Trial Information

Phase II Clinical Trial Of Bevacizumab (IND 7,921; NSC 704865) And Low Dose Oral Cyclophosphamide In Recurrent Ovarian Cancer, Primary Peritoneal Carcinoma

OBJECTIVES: Primary I. Determine the time to progression in patients with recurrent ovarian
epithelial or primary peritoneal cancer treated with bevacizumab and low-dose

Secondary I. Determine the response rate in patients treated with this regimen. II.
Determine the toxicity of this regimen in these patients. III. Determine molecular
correlates for response and outcomes in patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course
and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral
cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 1-2

Inclusion Criteria:

- Histologically confirmed recurrent or metastatic ovarian epithelial or primary
peritoneal cancer

- Unidimensionally measurable disease

- Previously irradiated indicator lesions must have progressed after radiotherapy

- Received a platinum-containing regimen for primary disease

- No more than 2 prior chemotherapy regimens for recurrent disease

- Must have received prior platinum-based chemotherapy for recurrent disease if it
has been > 12 months since treatment for primary disease (except if
hypersensitivity to platinum has developed)

- Rechallenge with the same platinum-based regimen is considered 1 prior regimen

- No history or clinical evidence of CNS disease, including primary brain tumor

- No brain metastases

- Performance status - SWOG 0-2

- At least 3 months

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No bleeding diathesis

- No coagulopathy

- Bilirubin no greater than 1.5 times normal

- ALT or AST no greater than 3 times upper limit of normal

- INR less than 1.5 (for patients receiving warfarin)

- Creatinine no greater than 1.5 times normal

- No proteinuria (less than 1+)

- Proteinuria less than 500 mg/24-hour urine collection

- No prior deep vein thrombosis

- No prior stroke

- No clinically significant cardiovascular disease

- None of the following within the past year:

- Uncontrolled hypertension

- New York Heart Association class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Grade II or greater peripheral vascular disease

- None of the following within the past 6 months:

- Unstable angina

- Myocardial infarction

- Transient ischemic attack

- Cerebrovascular accident

- Other arterial thromboembolic event

- No clinically significant peripheral artery disease

- No active infection requiring parenteral antibiotics

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No serious, non-healing wound, ulcer, or bone fracture

- No significant traumatic injury within the past 28 days

- No seizures not controlled with standard medical therapy

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- All prior invasive malignancies must be in complete remission

- No other concurrent medical, psychological, or social condition that would preclude
study participation

- No prior antiangiogenesis agents

- See Disease Characteristics

- Recovered from prior chemotherapy

- See Disease Characteristics

- Recovered from prior radiotherapy

- More than 28 days since prior major surgical procedure or open biopsy and recovered

- At least 3 weeks since prior therapy directed at the malignancy

- No recent or concurrent full-dose anticoagulants or thrombolytic agents

- Anticoagulants to maintain patency of preexisting, permanent indwelling IV
catheters allowed

- No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal
anti-inflammatory drugs known to inhibit platelet function

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival defined according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

Kaplan-Meier plots will be constructed. Cox proportional hazards model will be used.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Agustin Garcia

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



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