Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00561795
• Date of registration: 19/11/2007
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00561795
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Belgium, France, Germany

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- Inclusion Criteria

- 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.

- 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.

Exclusion Criteria

- 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

- 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


Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cancer

Epithelial Ovarian Cancer

Primary Peritoneal Carcinoma

Uterine Disease

Tumor

Cervix Diseases

Neoplasms, Ovarian

Intervention(s)

Drug: carboplatin

Drug: pazopanib (GW786034)

Drug: paclitaxel

Primary Outcome(s)

Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events [Time Frame: Baseline to End of Study (up to a year)]

Secondary Outcome(s)

18-week Progression Free Survival [Time Frame: Baseline to Week 18]

Overall Response [Time Frame: Baseline until either response or progression (up to 2 years)]

Cancer Antigen (CA-125) Response [Time Frame: Baseline until response (up to 2 years)]

Secondary ID(s)

VEG110190

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/12/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00561795