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A Phase 2 Study of BAY 43-9006 in Combination With Gemcitabine in Recurrent Epithelial Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

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Trial Information

A Phase 2 Study of BAY 43-9006 in Combination With Gemcitabine in Recurrent Epithelial Ovarian Cancer

PRIMARY OBJECTIVES I. Objective tumour response rate (complete plus partial response as
defined by the RECIST criteria) in women with recurrent or refractory advanced ovarian or
primary peritoneal cancer.


I. Median survival time. II. 6-month survival rate. III. Objective tumour stable disease
rate. IV. Response duration. V. Toxicity. VI. Time to disease progression.

OUTLINE: This is a multicenter study.

Course 1 (56 days): Patients receive oral sorafenib twice daily on days 1-56 and gemcitabine
IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.

Course 2 and all subsequent courses (28 days): Patients receive oral sorafenib twice daily
on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.

Patients with a complete or partial response receive at least 2 additional courses beyond
documented response. Patients with stable or responding disease who have received at least 6
courses may discontinue gemcitabine and continue sorafenib alone until disease progression.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed epithelial ovarian
cancer or primary peritoneal cancer that has recurred or is refractory to initial
therapy; patients must have received platinum-based chemotherapy before entry into
this protocol

- Patients who have recurred and are platinum-sensitive (treatment free interval
greater than 12 months) must have been re-treated with platinum-based chemotherapy
prior to entry into this protocol

- Patients may have received no more than three prior chemotherapy regimens (e.g.
initial chemotherapy and two regimens for subsequent relapses)

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
20 mm with conventional techniques or as >= 10 mm with spiral CT scan; if measurable
disease is in a radiated site, there must be evidence of disease progression in that
lesion post radiation

- Life expectancy of greater than 12 weeks

- ECOG performance status =<1 (Karnofsky >= 70%)

- Leukocytes >= 3,000/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- The effects of BAY 43-9006 on the developing human fetus at the recommended
therapeutic dose are unknown; for this reason and because raf kinase inhibitor agents
as well as other therapeutic agents used in this trial are known to be teratogenic,
women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately

- Ability to understand and the willingness to sign a written informed consent document

- Patients who are on warfarin anticoagulation are allowed to participate as long as
they fit the following 4 criteria:

- They are therapeutic on a stable warfarin dose

- Their INR target range is no greater than 3

- They are monitored with weekly INR, PT and PTT testing

- They have no active bleeding or pathological condition that carries high risk of

- Pregnant women are excluded from this study because BAY 43-9006 is a kinase inhibitor
agent with the potential for teratogenic or abortifacient effects; because there is
an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with BAY 43-9006, breastfeeding should be discontinued if the
mother is treated with BAY 43-9006

Exclusion Criteria:

- Patients who have had chemotherapy, radiotherapy, hormonal or biologic therapy within
4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or
those who have not recovered from adverse events due to agents administered more than
4 weeks earlier

- Patients with borderline tumours or tumours of low malignant potential

- Patients with current bowel obstruction

- Patients with previous radiotherapy to > 30% of bone marrow irradiated in target
volume and/or radiotherapy within 4 weeks of study treatment; palliative radiation is
allowed within 4 weeks of treatment, after discussion with the Principal Investigator

- Patients may not be receiving any other investigational agents concurrently or within
4 weeks; patients who have previous exposure to a raf-kinase inhibitor are excluded

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to BAY 43-9006 or other agents used in the study

- Patients may not have had prior gemcitabine chemotherapy

- No concurrent use of itraconazole, ketoconazole, ritanovir, or grapefruit juice

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements

- Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with BAY 43-9006; appropriate studies will be undertaken
in patients receiving combination anti-retroviral therapy when indicated

Type of Study:


Study Design:

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

Outcome Measure:

Objective tumor response rate (complete plus partial response as defined by the RECIST criteria)

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

Amit Oza

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital Phase 2 Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

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