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A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination With Gemcitabine and the Effect of Tumor-Based HER2 Activation in Subjects With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer


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

Thank you

Trial Information

A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination With Gemcitabine and the Effect of Tumor-Based HER2 Activation in Subjects With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer


Inclusion Criteria:



- Signed informed consent

- Age >= 18 years

- Advanced, histologically documented ovarian, primary peritoneal, or fallopian tube
carcinoma

- Representative tumor specimens in paraffin blocks or at least 12 unstained slides
with an associated pathology report, obtained at any time prior to entry of study for
evaluation of HER2 activation

- Measurable disease with at least one lesion that can be accurately measured in at
least one dimension (longest dimension recorded), Or:

- Clinically or radiologically detectable disease (e.g., ascites, peritoneal deposits,
mesenteric thickening or lesions that do not fulfill RECIST for measurable disease)

- Platinum-resistant or refractory carcinoma

- Life expectancy >= 12 weeks

- ECOG performance status 0 or 1

- LVEF >= 50%, as determined by ECHO

- Use of an effective means of contraception (for women of childbearing potential)

- Clinical laboratory test results: Granulocyte count >= 1500/uL; Platelet count >=
75,000/uL; Hemoglobin >= 9 g/dL (hemoglobin may be supported by transfusion or
erythropoietin or other approved hematopoietic growth factors; darbopoeitin
[Aranesp(R)] is permitted); Serum bilirubin <= 1.5 the ULN; Alkaline phosphatase,
AST, and ALT <= 2.5 ULN (AST, ALT <= 5 ULN for subjects with liver metastasis); Serum
creatinine <= 1.5 ULN; International normalized ratio (INR) <= 1.5 and activated
partial thromboplastin time (aPTT) <= 1.5 ULN (except for subjects receiving
anti-coagulation therapy)

Exclusion Criteria:

- Prior treatment with gemcitabine

- Two or more prior regimens for the treatment of platinum-resistant disease

- Two or more non-platinum-containing regimens for the treatment of platinum-sensitive
disease

- Prior treatment with experimental anti-cancer agents within 4 weeks prior to Day 1
(the day the first study treatment infusions are administered)

- Prior treatment with HER2 pathway inhibitors (e.g., Herceptin(R) [trastuzumab],
Iressa(R) [gefitinib], Tarceva [erlotinib hydrochloride], cetuximab, GW572016)

- History or clinical evidence of central nervous system or brain metastases

- Uncontrolled hypercalcemia ( > 11.5 mg/dL)

- Prior exposure of > 360 mg/m^2 doxorubicin or liposomal doxorubicin, > 120 mg/m^2
mitoxantrone, or > 90 mg/m^2 idarubicin

- History of other malignancies within 5 years of Day 1, except for adequately treated
carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, basal or
squamous cell skin cancer

- History of serious systemic disease, unstable angina, myocardial infarction within 6
months prior to Day 1 of treatment, symptoms of CHF, or unstable symptomatic
arrhythmia requiring medication (subjects with chronic atrial arrhythmia [i.e.,
atrial fibrillation, paroxysmal supraventricular tachycardia] are eligible)

- Known HIV infection

- Pregnancy or lactation

- Major surgery or significant traumatic injury within 3 weeks prior to Day 1 of
treatment

- Inability to comply with study and follow-up procedures

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the subject at high risk from treatment
complications

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

To assess the efficacy and to evaluate the safety and tolerability of pertuzumab in combination with gemcitabine relative to gemcitabine in combination with placebo in subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer

Principal Investigator

Virginia Patton, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

TOC3258g

NCT ID:

NCT00096993

Start Date:

November 2004

Completion Date:

August 2007

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Omnitarg
  • Cancer
  • Platinum-Resistant
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
Carle Clinic Association Urbana, Illinois  61801
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cedars-Sinai Medical Center Los Angeles, California  90048
Sutter Cancer Center Sacramento, California  95816
Franklin Square Hospital Center Baltimore, Maryland  21237
Carolinas Medical Center Charlotte, North Carolina  28232-2861
North Idaho Cancer Center Coeur d'Alene, Idaho  83814
Comprehensive Cancer Institute Huntsville, Alabama  35801
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Center for Cancer And Hematologic Disease Cherry Hill, New Jersey  08046
Greater Baltimore Medical Center Baltimore, Maryland  21204
Hematology Oncology, P.C. Stamford, Connecticut  06902
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
University of Chicago Chicago, Illinois  60637
University of Kentucky Lexington, Kentucky  40536-0098
University of California, Los Angeles Los Angeles, California  
Sharp Healthcare San Diego, California  92121
Indiana University Indianapolis, Indiana  46202
Florida Hospital Orlando, Florida  32803
Cancer Center of Kansas Wichita, Kansas  67214
St. Luke's Mountain States Tumor Institute Boise, Idaho  83712
Univ. of Alabama at Birmingham Birmingham, Alabama  35233
Northwest Alabama Cancer Center Muscle Shoals, Alabama  35661
Alta Bates Comp. Cancer Ctr Berkeley, California  94704
California Cancer Crae, Inc Greenbrae, California  94904
Ventura County Hematology Oncology Specialists Oxnard, California  93030
Southern California Permanente Medical Group (Kaiser) San Diego, California  92120
Norwalk Medical Group Norwalk, Connecticut  06856
Memorial Health Univ. Med. Ctr. Savannah, Georgia  31404
St. Vincent Hospital Indianapolis, Indiana  46260
Wayne State Univ. Barbara Ann Karmanos Cancer Inst. Detroit, Michigan  48201
Cooper Health System Voorhees, New Jersey  08043
Pelvic Surgery Assoc. Columbus, Ohio  43222
Ohio State University College of Medicaine Columbus, Ohio  43210
Oklahoma Univ. Medical Center Oklahoma City, Oklahoma  73104
Corvallis Clinic Corvallis, Oregon  97330
Kaiser Permanente Northwest Division Portland, Oregon  97227
Womens and Infants Hospital Providence, Rhode Island  02905
Northern Virginia Pelvic Surgery Assoc. Annandale, Virginia  22003
Carilion Gyn/Onc Roanoke, Virginia  24014