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A Phase II Trial of Oral Sorafenib (Bay43-9006) In Women With Epithelial Ovarian, Fallopian Tube Or Peritoneal Carcinoma In Second Or Greater Remission

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Trial of Oral Sorafenib (Bay43-9006) In Women With Epithelial Ovarian, Fallopian Tube Or Peritoneal Carcinoma In Second Or Greater Remission



- To determine the 12-month progression-free survival (PFS) rate of women with ovarian
epithelial, fallopian tube, or peritoneal cancer in second or greater remission treated
with oral sorafenib tosylate.


- To determine the safety and tolerability of prolonged treatment with oral sorafenib
tosylate in women with a history of recurrent ovarian cancer.

- To correlate serum markers of angiogenesis (i.e., VEGF and bFGF) and tumor markers
pAKT, HIF-1 α , and VEGF with 12-month PFS.

OUTLINE: Patients receive oral sorafenib twice a day on days 1-28. Treatment repeats every
28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection at baseline, every 12 weeks during
study, and after completion of study therapy for pharmacokinetic studies. Samples are
analyzed for soluble markers of angiogenesis (i.e., VEGF and bFGF) via ELISA and HIF-1 α,
VEGF, and pAKT via IHC staining.

After completion of study treatment, patients are followed at 4 weeks.

Inclusion Criteria


- Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube,
or peritoneum

- Any stage and grade at diagnosis

- Must have received initial cytoreductive surgery and chemotherapy with ≥ 1
platinum-based chemotherapy regimen

- Persistent or recurrent disease after initial therapy

- In complete clinical remission after chemotherapy for recurrent disease, meeting all
of the following criteria:

- CA125 ≤ 35 units/L

- Normal physical examination

- No definite evidence of disease by CT scan of the abdomen and pelvis

- Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm are not considered
definite evidence of disease

- No known brain metastases


Inclusion criteria:

- Karnofsky performance status 70-100%

- Life expectancy > 3 months

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- INR < 1.5 OR PT/PTT within normal limits

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Urinalysis negative for protein

- If urinalysis shows 1+ protein by dipstick or protein ≥ 30-100 mg/dL by
semi-quantitative assay, a 24-hour urine collection is required

- Eligible patients must have a total urinary protein ≤ 500 mg AND measured
creatinine clearance ≥ 50 mL/min from a 24-hour urine collection

- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Stable blood pressure (BP) measurement required on 3 separate days prior to the start
of treatment

- No peripheral neuropathy > grade 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

Exclusion criteria:

- Other invasive malignancies within the past 5 years, except nonmelanoma skin cancer

- Uncontrolled concurrent illness or medical condition including, but not limited to,
any of the following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Uncontrolled diabetes

- Psychiatric illness or social situation that would preclude study compliance

- Uncontrolled hypertension defined as a persistent BP > 150/100 mm Hg (or a persistent
BP > 180/90 mm Hg if the patient has a history of isolated systolic hypertension)
despite ≥ 2 attempts at antihypertensive medication dosage adjustment ≥ 2 weeks apart

- Thrombolic or embolic events such as cerebrovascular accident, including transient
ischemic attack, within the past 6 months

- Pulmonary hemorrhage or bleeding event ≥ grade 2 within 4 weeks of the first dose of
study drug

- Other hemorrhage or bleeding event ≥ grade 3 within 4 weeks of the first dose of
study drug

- Serious nonhealing wound, ulcer, or bone fracture

- Evidence or history of bleeding diathesis or coagulopathy

- Inability to take oral medications or gastrointestinal condition that compromises

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sorafenib tosylate


Inclusion criteria:

- See Disease Characteristics

- No prior sorafenib tosylate or other inhibitors of MAPK signaling intermediates or
angiogenesis inhibitors

- No prior cancer treatment that would contraindicate protocol therapy

- More than 4 weeks since prior radiotherapy

- More than 3 weeks since prior chemotherapy, biological therapy, or immunotherapy

- More than 1 week since prior hormonal therapy for cancer treatment

Exclusion criteria:

- Major surgery (i.e., laparotomy) within the past 4 weeks or minor surgery within the
past 2 weeks

- Placement of a vascular access device is not considered minor surgery

- Concurrent combination antiretroviral therapy for HIV-positive patients

- Concurrent St. John wort, rifampin, or enzyme-inducing anticonvulsants (e.g.,
carbamazepine, phenytoin, or phenobarbital)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) rate at 12 months

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

William P. Tew, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

March 2008

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



Memorial Sloan - Kettering Cancer Center New York, New York  10021