Phase 2
N=33
Pazopanib Hydrochloride in Treating Patients With Stage IV or Recurrent Nasopharyngeal Cancer
Recurrent Lymphoepithelioma of the Nasopharynx · Recurrent Squamous Cell Carcinoma of the Nasopharynx · Stage IV Lymphoepithelioma of the Nasopharynx · Stage IV Squamous Cell Carcinoma of the Nasopharynx
Bottom Line
View on ClinicalTrials.gov: NCT00454142 ↗Enrolled (actual)
33
Serious AEs
30.3%
Results posted
Dec 2015
Primary outcome: Primary: Clinical Benefit Rate — 54.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pazopanib hydrochloride (Drug); pharmacological study (Other); computed tomography (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate |
54.5 | — |
| SECONDARY Response Rate (PR) |
6.1 | — |
| SECONDARY Progression-free Survival |
4.4 | — |
| SECONDARY Overall Survival |
10.8 | — |
| SECONDARY Toxicity Profile: Percentage of Participants With Significant (Grade 3/4) Related Adverse Event (AE) |
48 | — |
| SECONDARY Pharmacodynamic Study: Tumor Blood Flow at Baseline |
52.2 | — |
| SECONDARY Pharmacodynamic Study: Tumor Blood Flow on Day 28 |
35.7 | — |
| SECONDARY Pharmacokinetic Study: Percentage of Participants With Trough Concentration at Steady State (Day 28) Above 15 µg/mL |
92 | — |
| SECONDARY Pharmacokinetic Study: AUC0-24h/Dose on Day 1 |
836.23 | — |
| SECONDARY Pharmacokinetic Study: Area Under Curve (AUC) 0-24h/Dose on Day 28 |
1192.35 | — |
| SECONDARY Pharmacokinetic Study: Volume of Distribution (Vd/F/Dose) on Day 1 |
18.09 | — |
| SECONDARY Pharmacokinetic Study: Volume of Distribution at Steady State (Vss/F/Dose) on Day 28 |
80.23 | — |
Summary
This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed nasopharyngeal carcinoma, meeting the following criteria:
- World Health Organization (WHO) type II-III disease
- Stage IV or recurrent disease
- Must have failed at least 1 prior line of chemotherapy for metastatic or recurrent disease
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- No known brain metastases
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 70-100%
- Life expectancy > 3 months
- WBC >= 3,000/mm³
- Absolute neutrophil count >= 1,500/mm³
- Platelet count >= 100,000/mm³
- Bilirubin normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = = 60 mL/min
- Proteinuria = = 1 week apart
- Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) = = 500 msec)
- No serious or non-healing wound, ulcer, or bone fracture
- No condition that would impair the ability to swallow and retain pazopanib hydrochloride, including any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication
- Requirement for IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
- No concurrent uncontrolled illness including, but not limited to, the following:
- Coagulopathy
- Ongoing or active infection
- Psychiatric illness or social situation that would preclude study compliance
- No known allergy to CT contrast agents
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
- More than 4 weeks since prior radiotherapy
- At least 4 weeks since prior surgery
- No prior antiangiogenesis therapy
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of pazopanib hydrochloride, as determined by the Principal Investigator
- No concurrent medications that have the potential to interact with the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4
- No concurrent therapeutic warfarin
- Low molecular weight heparin or prophylactic low-dose warfarin allowed
- No concurrent antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
Data sourced from ClinicalTrials.gov (NCT00454142). 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.