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AE-941 (NEOVASTAT) Versus Placebo in Metastatic Renal Cell Carcinoma Patients Who Are Refractory to Immunotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

AE-941 (NEOVASTAT) Versus Placebo in Metastatic Renal Cell Carcinoma Patients Who Are Refractory to Immunotherapy


OBJECTIVES: I. Compare survival of patients with metastatic renal cell carcinoma refractory
to immunotherapy treated with AE-941 (Neovastat) versus placebo. II. Compare the time to
progression and one-year survival rate of patients treated with this regimen. III. Determine
the safety of this regimen in these patients. IV. Compare the overall tumor response rate,
duration of response, and quality of life of patients treated with this regimen.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to number of organs with metastases (1 vs more than 1) and ECOG
performance status (0 vs 1). Patients are randomized to one of two treatment arms. Arm I:
Patients receive oral AE-941 (Neovastat) twice a day. Arm II: Patients receive oral placebo
twice a day. Treatment continues in the absence of unacceptable toxicity or disease
progression. Quality of life is assessed on day 1 and then every 8 weeks thereafter.
Patients are followed every 4 weeks until disease progression and then every 8 weeks
thereafter.

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed renal cell adenocarcinoma Disease
progression within 16 weeks after first-line therapy, which included interleukin-2 and/or
interferon Metastatic disease not amenable to surgery Measurable and/or evaluable disease
No more than one line of prior anticancer treatment for renal cell carcinoma No pure
papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini
carcinoma, medullary carcinoma, or chromophobe oncocytic tumor No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
More than 3 months Hematopoietic: Platelet count at least 100,000/mm3 WBC at least
2,500/mm3 Hemoglobin at least 8 g/dL (epoetin alfa allowed) Hepatic: Not specified Renal:
Calcium no greater than the upper limit of normal (ULN) (bisphosphonates allowed)
Creatinine no greater than 2 times ULN Other: No other prior malignancy within past 5
years except basal cell carcinoma of the skin or carcinoma in situ of the cervix No severe
allergy to fish or seafood No medical condition that would interfere with intake and/or
absorption of study medication (e.g., gastrectomy or major intestinal resection) No
significant medical or psychiatric condition that would preclude study Not pregnant
Negative pregnancy test Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month
but no longer than 8 months since prior immunotherapy Chemotherapy: Not specified
Endocrine therapy: At least 1 week since prior systemic corticosteroids for symptomatic
treatment of renal cell carcinoma At least 28 days since prior medroxyprogesterone acetate
No concurrent medroxyprogesterone acetate Concurrent corticosteroids for symptomatic
treatment of neurological complications caused by renal cancer allowed Radiotherapy:
Concurrent radiotherapy to symptomatic lesions for symptom relief allowed Surgery: See
Disease Characteristics Concurrent surgical removal of symptomatic lesions for symptom
relief allowed Other: At least 28 days since other prior experimental therapeutic agents
At least 28 days since other prior shark cartilage products No other concurrent therapies
for metastatic renal cell carcinoma No other concurrent shark cartilage products

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

CDR0000067999

NCT ID:

NCT00005995

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

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