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Phase 2 Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer

Phase 2
18 Years
Open (Enrolling)
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

Phase 2 Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer


I. Determine the frequency of major response in patients with metastatic renal cell cancer
treated with bevacizumab and interleukin-2.

SECONDARY OBJECTIVES I. Compare the median progression-free survival and median overall
survival of patients treated with this regimen with risk-stratified historical controls from
published risk models.


Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11.
Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment
repeats every 12 weeks for up to 2 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab
alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks
in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 3
months for at least 2 years.

PROJECTED ACCRUAL: Approximately 10-38 patients will be accrued for this study within 21

Inclusion Criteria:

- Histologically or cytologically confirmed renal cell cancer

- Metastatic disease

- More than 75% clear cell histology

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- No prior refractory disease, defined as clinical or radiologic progression, during or
within 3 months after completion of prior interleukin-2 (IL-2)

- Nominally "good" or "intermediate" risk disease, meeting ≥ 4 out of 5 of the
following criteria:

- Hemoglobin > 10 g/dL (except for patients with hereditary hemoglobinopathy)

- ECOG performance status 0-1 (required)

- Calcium normal (corrected)

- Patients with hypercalcemia due to malignancy allowed provided it has been
controlled for > 1 month

- Primary tumor treated or resected by complete nephrectomy, partial nephrectomy,
radiofrequency ablation, or other local ablation

- Lactic dehydrogenase < 1.5 times upper limit of normal (ULN)

- No history of or current brain or CNS metastasis by CT scan or MRI within the past 30

- Performance status - ECOG 0-1

- More than 4 months

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm^3

- No history of bleeding diathesis

- PTT < 1.5 times ULN

- INR < 1.5

- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 2.5 times ULN

- No chronic hepatitis B or C

- Creatinine ≤ 2.0 mg/dL

- No proteinuria* by dipstick urinalysis

- Urine protein ≤ 1,000 mg by 24-hour urine collection

- No symptomatic congestive heart failure

- No uncontrolled hypertension, defined as systolic blood pressure (BP) > 160 mm Hg and
diastolic BP > 90 mm Hg

- No cardiac arrhythmia

- No peripheral vascular disease ≥ grade 2

- No clinically significant peripheral artery disease

- None of the following arterial thromboembolic events within the past 6 months:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina pectoris

- Myocardial infarction

- Not pregnant

- No nursing during and for 3 months after completion of study treatment

- Negative pregnancy test

- Fertile patients must use effective contraception before, during, and for 3 months
after completion of study treatment

- No active infection requiring parenteral antibiotics

- No known HIV positivity

- No history of allergic reaction to antibody drugs or IL-2

- No psychiatric illness or social situation that would preclude study compliance

- No non-healing wound or fracture

- No insulin-dependent diabetes

- No other uncontrolled illness

- No other malignancy requiring active treatment within the past 2 years except
nonmelanoma skin cancer

- No prior bevacizumab

- At least 6 months since prior immunotherapy containing IL-2

- At least 2 months since prior investigational antibodies

- More than 4 weeks since prior conventional cytotoxic chemotherapy (6 weeks for
nitrosoureas or mitomycin) and recovered

- No concurrent corticosteroids except replacement corticosteroids for adrenal
insufficiency OR inhaled steroids for chronic obstructive pulmonary disease, asthma,
or allergic rhinitis

- More than 3 weeks since prior radiotherapy and recovered

- No prior radiotherapy to the only site of measurable disease unless there has been
subsequent disease progression

- More than 4 weeks since prior major surgery

- At least 24 hours since prior minor surgical procedure, placement of vascular access
device, or fine needle aspiration

- At least 30 days since prior and no other concurrent investigational agents

- More than 10 days since prior anticoagulants

- Low-dose anticoagulants for maintenance of vascular access device patency

- No concurrent therapeutic warfarin, including warfarin for treatment of deep vein
thrombosis or pulmonary embolism

- No other concurrent anticancer therapy

Type of Study:


Study Design:

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

Outcome Measure:

Major response (complete response [CR] and partial response [PR]) according to RECIST

Outcome Description:

An exact one-sided 95% confidence interval for the major response rate will be computed using the method of Clopper and Pearson.

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Mayer Fishman

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2005

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612