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SORCE: A Phase III Randomised Double-Blind Study Comparing Sorafenib With Placebo in Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

SORCE: A Phase III Randomised Double-Blind Study Comparing Sorafenib With Placebo in Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse


OBJECTIVES:

- Compare disease-free survival of patients with resected primary renal cell carcinoma at
high- or intermediate-risk of relapse treated with a placebo for 3 years vs a placebo
for 2 years and sorafenib tosylate for 1 year vs sorafenib tosylate for 3 years.

OUTLINE: This is a randomized, placebo-controlled, double-blind, open-label, multicenter
study. Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive oral placebo twice daily for 3 years in the absence of disease
progression or unacceptable toxicity.

- Arm II: Patients receive oral sorafenib tosylate twice daily for 1 year and oral
placebo twice daily for 2 years in the absence of disease progression or unacceptable
toxicity.

- Arm III: Patients receive oral sorafenib tosylate twice daily for 3 years in the
absence of disease progression or unacceptable toxicity.

Patients in arms I and II with progressive disease may cross over and receive treatment in
arm III.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma (RCC)

- Clear cell or non-clear cell tumors allowed

- Intermediate- or high-risk disease (Leibovich score 3 to 11)

- Must have undergone surgery for RCC at least 4 weeks but no more than 3 months prior
to study entry

- No evidence of residual macroscopic disease on post-operative CT scan after
resection of RCC

PATIENT CHARACTERISTICS:

- WHO performance status 0-1

- WBC > 3,400/mm³

- Platelet count > 99,000/mm³

- Creatinine < 2.5 times upper limit of normal (ULN)

- Liver function tests < 1.5 times ULN

- Serum amylase < 1.5 times ULN

- PT/INR < 1.5 times ULN

- PTT < 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 9 months after
completion of study treatment

- No cardiovascular conditions, including any of the following:

- Cardiac arrhythmias requiring anti-arrhythmic medication

- Beta-blockers and digoxin allowed

- Symptomatic coronary artery disease or ischemia

- Myocardial infarction within the past 6 months

- NYHA class II-IV congestive heart failure

- No active clinically serious bacterial or fungal infection

- No known history of HIV infection

- No chronic hepatitis B or C

- No other prior malignancy except carcinoma in situ of the cervix or adequately
treated basal cell carcinoma

- No uncontrolled hypertension

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior treatment for RCC other than nephrectomy

- More than 30 days since prior and no other concurrent investigational therapy

- No concurrent medications that have adverse interactions with sorafenib tosylate
including, but not limited to, any of the following:

- Rifampin

- Grapefruit juice

- Ritonavir

- Ketoconazole

- Itraconazole

- Hypericum perforatum (St John's wort)

- No concurrent bone marrow transplant or stem cell rescue

- No other concurrent drug that targets angiogenesis, especially VEGF or VEGF receptors
(e.g., bevacizumab)

- No other concurrent drug that targets Ras-pathway or EGFR

- No other concurrent anticancer therapy (chemotherapy, immunotherapy, signal
transduction inhibition, or hormonal therapy)

- Concurrent non-conventional therapies (e.g., herbs or acupuncture) and vitamin or
mineral supplements allowed

- Concurrent bisphosphonates for prophylaxis of osteoporosis allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Timothy Eisen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Research UK at Cambridge Research Institute

Authority:

Unspecified

Study ID:

CDR0000553251

NCT ID:

NCT00492258

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage II renal cell cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • stage I renal cell cancer
  • clear cell renal cell carcinoma
  • papillary renal cell carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

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