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Ovarian CancerPhase 2NCT00096993

A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 2 study testing Gemcitabine and Pertuzumab in people with Ovarian Cancer and Peritoneal Cancer, run by Genentech, Inc. at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Gemcitabine and Pertuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
41 sitesUnited States
Study dates
Jan 2005to Sep 2007
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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<TM> [erlotinib hydrochloride], cetuximab, GW572016)
  • History or clinical evidence of central nervous system or brain metastases
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  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Northern Virginia Pelvic Surgery Assoc.

    Annandale, Virginia, 22003

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Alta Bates Comp. Cancer Ctr

    Berkeley, California, 94704

  • Univ. of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • St. Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Center for Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • University Of Chicago

    Chicago, Illinois, 60637

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Ohio State University College of Medicaine

    Columbus, Ohio, 43210

  • Pelvic Surgery Assoc.

    Columbus, Ohio, 43222

  • Corvallis Clinic

    Corvallis, Oregon, 97330

  • Wayne State Univ. Barbara Ann Karmanos Cancer Inst.

    Detroit, Michigan, 48201

  • California Cancer Crae, Inc

    Greenbrae, California, 94904

  • Comprehensive Cancer Institute

    Huntsville, Alabama, 35801

  • Indiana University

    Indianapolis, Indiana, 46202

  • St. Vincent Hospital

    Indianapolis, Indiana, 46260

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Norwalk Medical Group

    Norwalk, Connecticut, 06856

  • Oklahoma Univ. Medical Center

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital

    Orlando, Florida, 32804

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Kaiser Permanente Northwest Division

    Portland, Oregon, 97227

  • Womens and Infants Hospital

    Providence, Rhode Island, 02905

  • Carilion Gyn/Onc

    Roanoke, Virginia, 24014

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Southern California Permanente Medical Group (Kaiser)

    San Diego, California, 92120

  • Sharp Healthcare

    San Diego, California, 92123

  • Memorial Health Univ. Med. Ctr.

    Savannah, Georgia, 31404

  • Hematology Oncology, P.C.

    Stamford, Connecticut, 06902

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Carle Clinic Association

    Urbana, Illinois, 61801

  • Cooper Health System

    Voorhees Township, New Jersey, 08043

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: 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

This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.

Being tested
Placebo, Gemcitabine, Pertuzumab
Keywords
Omnitarg, Cancer, Platinum-Resistant
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo was provided as a single-use formulation for infusion.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine was provided as a solution for infusion.

  • PertuzumabDrug

    Also called rhuMAb 2C4

    Pertuzumab was provided as a single-use formulation for infusion.

Study groups in NCT00096993
Study groupRoleWhat they receive
Placebo + gemcitabinePlacebo comparatorParticipants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Receives: Drug: Placebo; Drug: Gemcitabine
Pertuzumab + gemcitabineActive comparatorParticipants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Receives: Drug: Gemcitabine; Drug: Pertuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.

    Measured: Baseline to the end of the study (up to 1 year)

Secondary outcomes (4)

  1. Percentage of Participants With an Objective Response

    An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.

    Measured: Baseline to the end of the study (up to 1 year)

  2. Duration of the Objective Response

    Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.

    Measured: Baseline to the end of the study (up to 1 year)

  3. Percentage of Participants Free From Disease Progression at 4 Months

    Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Baseline to Month 4

  4. Duration of Survival

    Duration of survival was defined as the time from randomization until death from any cause.

    Measured: Baseline to the end of the study (up to 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2004 (estimated)
  2. Study startJan 2005
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096993
Sponsor's protocol ID
TOC3258g
Status last verified
Jun 2015
First submitted
17 Nov 2004
Last updated
10 Jun 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and Pertuzumab in people with Ovarian Cancer and Peritoneal Cancer, run by Genentech, Inc. at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: Baseline to the end of the study (up to 1 year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.

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