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Primary Peritoneal CarcinomaPhase 2NCT00561795

Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors

A Phase 2 study testing pazopanib (GW786034), carboplatin and paclitaxel in people with Primary Peritoneal Carcinoma and Tumor, run by GlaxoSmithKline at 5 sites in 2 countries.

Completed

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

Official record
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Trial summary

This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
pazopanib (GW786034), carboplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
5 sitesin 2 countries
Study dates
Sep 2007to Apr 2008
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

  • A subject will be considered eligible for inclusion in this study only if all of the following criteria are met:
  • Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up.
  • Procedures conducted as a part of routine clinical management of the subject (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for Screening or Baseline purposes provided these tests are obtained as specified in the protocol).
  • Female subjects ≥18 years of age with newly diagnosed advanced gynaecological malignancies for whom carboplatin and paclitaxel based chemotherapy is indicated. Patients may have surgery to debulk or resect disease but may not have received chemotherapy or radiotherapy.
  • Histological confirmation of the following: epithelial ovarian cancer, endometrial carcinoma, uterine sarcoma, mixed Müllerian tumour, fallopian tube carcinoma, primary peritoneal carcinoma, cervical carcinoma or vulvar carcinoma.
  • Performance status must be ECOG 0 1.
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  • Adequate organ system function as defined in Table 6
  • Table 6 Definitions for Adequate Organ Function
  • System (Laboratory Values)
  • Hematologic:
  • Absolute neutrophil count (ANC) (≥ 1.5 X 109/L)
  • Hemoglobin1 (≥9 g/dL)
  • Platelets (≥100 X 109/L)
  • International normalized ratio (INR)(≤ 1.2 X upper limit of normal (ULN))
  • Partial thromboplastin time (PTT) (≤1.2 X ULN)
  • Hepatic:
  • p Total bilirubin (≤1.5 X upper limit of normal (ULN))
  • AST and ALT (≤ 2.5 X ULN)
  • Renal:
  • Serum Creatinine (≤ 1.5 mg/dL)
  • Or, if serum creatinine >1.5 mg/dL, (≥ 50 mL/min)
  • Calculated creatinine clearance
  • Urine Protein to Creatinine Ratio2 (<1)
  • Patients may not have had a transfusion within 7 days of screening assessment.
  • If UPC ≥1, then a 24-hour urine protein must be assessed. Patients must have a 24-hour urine protein value <1g to be eligible.
  • Measurable or non-measurable disease.
  • A female subject is eligible to enter and participate in the study if she is:
  • Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:
  • Has had a hysterectomy, or
  • Has had a bilateral oophorectomy (ovariectomy), or
  • Has had a bilateral tubal ligation, or
  • Is post-menopausal
  • Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).
  • Subjects who are using hormone replacement therapy and whose menopausal status is in doubt will be required to use a highly effective method of contraception (as outlined in this inclusion criterion) if they wish to continue their HRT during the study. Otherwise, these subjects must discontinue HRT prior to study enrollment to allow confirmation of post menopausal status. For most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. Following confirmation of post menopausal status, these subjects can resume HRT during the study without use of contraception.
  • Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
  • An intrauterine device with a documented failure rate of less than 1% per year.
  • Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product.
  • Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
  • Note: Oral contraceptives are not reliable due to potential drug-drug interactions.
  • Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.
  • Recovered from the effects of surgery.
  • Prior radiotherapy is permissible, provided at least 4 weeks have elapsed since the last treatment to allow for full bone marrow recovery.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Prior use of anticancer therapy (except cytoreductive surgery [debulking]) for their cancer.
  • Presence of bulky, residual, squamous cell tumors.
  • Is unable to discontinue prohibited medications, as listed in Section 8.2 for 14 days or five half-lives of a drug prior to Visit 1 and for the duration of the study.
  • Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including but not limited to:
  • Malabsorption syndrome
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  • Major resection of the stomach or small bowel that could affect the absorption of study drug
  • Active peptic ulcer disease
  • Inflammatory bowel disease
  • Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
  • Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
  • Inadequately controlled hypertension (systolic blood pressure [SBP] of ≥140 mmHg, or diastolic blood pressure [DBP] of ≥ 90 mmHg). Initiation or adjustment of blood pressure medication is permitted prior to study entry provided the subject has 2 consecutive blood pressure readings less than 140/90 mmHg, each separated by a minimum of 24 hours. These readings need to be collected prior to the first dose.
  • Hemoptysis within four weeks prior to first dose of study drug.
  • Prior major trauma within 14 days prior to first dose of study drug.
  • Prior major surgery within 14 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. In the case of surgery involving the bowel, subjects must be 28 days post-surgery to be eligible.
  • Prolongation of corrected QT interval (QTc) > 480 msecs.
  • History of any one of more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA) [See History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents (excluding therapeutic warfarin) for at least 6 weeks are eligible.
  • Metastatic disease to the brain or leptomeninges.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Germany3 sites

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Marburg, Hesse, 35043

  • GSK Investigational Site

    Wiesbaden, Hesse, 65199

Other trials in Germany

France2 sites

  • GSK Investigational Site

    Lyon, 69373

  • GSK Investigational Site

    Strasbourg, 67085

Other trials in France

About this study

Official title: A Phase I/II, Open-Label, Multicenter, Two-Arm, Feasibility Study of Pazopanib, Carboplatin, and Paclitaxel in Women With Newly Diagnosed, Previously Untreated, Gynaecological Tumors

This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled. Dose schemas for each study arm are described in the protocol. For each arm, six subjects will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen 125 (CA-125) responses.

Being tested
pazopanib (GW786034), carboplatin, paclitaxel
Keywords
AGO, Advanced,, Gynaecologic cancer(s),, Genetics, GW786034,, Pazopanib,
Medical subject headings
Neoplasms, Carcinoma, Ovarian Epithelial, Uterine Diseases, Uterine Cervical Diseases, Ovarian Neoplasms

What participants receive

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

  • pazopanib (GW786034)Drug

    800 mg orally once a day for 6 cycles

  • carboplatinDrug

    IV over one hour every 3 weeks of 6 cycles

  • paclitaxelDrug

    IV 175 mg/m^2 given over 3 hours on day one of a 21 day cycle for six cycles

Study groups in NCT00561795
Study groupRoleWhat they receive
Arm AExperimentalOral Pazopanib 800 mg once a day+ carboplatin area under the concentration-time curve (AUC) 5 intravenous (IV) over 1 hour every 3 weeks + paclitaxel 175 mg/m^2 IV over three hours day one q 3 weeks for six cycles
Receives: Drug: pazopanib (GW786034); Drug: carboplatin; Drug: paclitaxel
Arm BExperimentalOral Pazopanib 800 mg once a day+ carboplatin AUC 6 IV over 1 hour every 3 weeks + paclitaxel 175 mg/m^2 IV over three hours day one q 3 weeks for six cycles
Receives: Drug: pazopanib (GW786034); Drug: carboplatin; Drug: paclitaxel

What is being measured

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

  1. Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events

    Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the "Adverse Event" section of the results record for additional details and data.

    Measured: Baseline to End of Study (up to a year)

Secondary outcomes (3)

  1. Overall Response

    Although the study protocol specified several efficacy analyses, due to poor tolerability of the combination regimen and the consequent early withdrawal of most participants, which led to a small sample size, efficacy analyses were not performed. Overall response is defined as the number of participants with CR or PR per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.

    Measured: Baseline until either response or progression (up to 2 years)

  2. Cancer Antigen (CA-125) Response

    Defined as the number of participants who achieved a confirmed CA-125 response, which is defined as at least a 50% reduction in CA-125 levels from a pre-treatment sample.

    Measured: Baseline until response (up to 2 years)

  3. 18-week Progression Free Survival

    Defined as the number participants who have not had radiological disease progression per RECIST, confirmed CA-125 progression, or death due to any cause by the end of 18 weeks.

    Measured: Baseline to Week 18

Timeline

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

  1. First posted21 Nov 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00561795
Sponsor's protocol ID
VEG110190
Status last verified
Mar 2011
First submitted
19 Nov 2007
Last updated
22 Mar 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib (GW786034), carboplatin and paclitaxel in people with Primary Peritoneal Carcinoma and Tumor, run by GlaxoSmithKline at 5 sites in 2 countries.

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 43 inclusion and 25 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 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, France. 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. 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 7 Dec 2010). 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?

Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events (time frame: Baseline to End of Study (up to a 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 NCT00561795.

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 22 Mar 2012.

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