Know Cancer

or
forgot password

A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer


PRIMARY OBJECTIVES :

I. Compare the progression-free and overall survival rate of patients with recurrent
platinum-sensitive ovarian epithelial, primary peritoneal, or fallopian tube cancer treated
with sorafenib with or without carboplatin and paclitaxel. (Arm I [sorafenib only] closed to
accrual 10/01/2008) II. Evaluate the response rate and time to disease progression in
patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to performance
status and participating center.

ARM I (closed to accrual 10/01/2008): Patients receive oral sorafenib twice daily on days
1-28.Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. Patients with disease progression crossover to arm II.

ARM II: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive
carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.


Inclusion Criteria:



- Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer

- Recurrent disease

- Must have received a prior platinum-based regimen

- Platinum-sensitive (treatment-free interval > 6 months)

- No more than 2 prior chemotherapy regimens

- Measurable disease

- At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR
>= 10 mm by spiral CT scan

- Not in a prior irradiation field

- No known brain metastases

- Performance status:

- ECOG 0-2 OR

- Karnofsky 80-100%

- Life expectancy:

- More than 12 weeks

- Hematopoietic:

- Absolute neutrophil count >= 1,500/mm3

- Platelet count >= 100,000/mm3

- Hemoglobin >= 9 g/dL

- No bleeding diathesis

- Hepatic:

- Bilirubin < 1.5 times upper limit of normal (ULN)

- AST or ALT =< 2 times ULN

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to sorafenib or other agents used in the study

- Patients who have had a reaction to a taxane or a platinum and have not yet been
rechallenged may undergo a desensitization regimen on study

- No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor El:

- Prior hypersensitivity reaction to paclitaxel allowed provided rechallenged
successfully

- Renal:

- Creatinine < 2 mg/dL

- Cardiovascular:

- Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed
if stable for the past 6 months

- No symptomatic congestive heart failure

- No uncontrolled hypertension

- No cardiac arrhythmia

- No unstable angina pectoris;

- No myocardial infarction within the past 6 months

- Negative pregnancy test

- Fertile patients must use effective contraception

- Adequate intestinal function

- No concurrent requirements for IV hydration or nutritional support

- No active or ongoing infection

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

- No other concurrent uncontrolled illness

- No other invasive malignancy with the past 5 years except nonmelanoma skin cancer

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

- More than 3 weeks since prior hormonal therapy

- More than 4 weeks since prior radiotherapy and recovered

- No prior sorafenib

- No prior anticancer therapy that contraindicates study therapy

- No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin,
carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent therapeutic anticoagulation therapy

- Concurrent prophylactic low-dose warfarin allowed for maintenance of venous or
arterial access devices

- No other concurrent anticancer therapies

- No other concurrent investigational agents

- Not pregnant or nursing

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

Outcome Description:

Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.

Outcome Time Frame:

after 6 weeks (2 cycles)

Safety Issue:

No

Principal Investigator

Steven Waggoner

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00067

NCT ID:

NCT00096200

Start Date:

August 2004

Completion Date:

Related Keywords:

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

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612