Phase 2
N=12
Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors
Primary Peritoneal Carcinoma · Tumor · Epithelial Ovarian Cancer · Uterine Disease · Cervix Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00561795 ↗Enrolled (actual)
12
Serious AEs
66.7%
Results posted
Dec 2010
Primary outcome: Primary: Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pazopanib (GW786034) (Drug); carboplatin (Drug); paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events |
— | — |
| SECONDARY Overall Response |
— | — |
| SECONDARY Cancer Antigen (CA-125) Response |
— | — |
| SECONDARY 18-week Progression Free Survival |
— | — |
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. 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.
Eligibility 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 ( 40 mIU/mL and an estradiol value 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.
Data sourced from ClinicalTrials.gov (NCT00561795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.