Phase 2
N=51
Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer
Gastrin-Producing Neuroendocrine Tumor · Lung Carcinoid Tumor · Metastatic Digestive System Neuroendocrine Tumor G1 · Multiple Endocrine Neoplasia Type 1 · Pancreatic Glucagonoma
Bottom Line
View on ClinicalTrials.gov: NCT00454363 ↗Enrolled (actual)
51
Serious AEs
31.4%
Results posted
Apr 2015
Primary outcome: Primary: Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) — 0; 6; 14; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Pazopanib Hydrochloride (Drug); Pharmacological Study (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) |
0; 6; 14; 21; 3; 3 | — |
| SECONDARY Percent Change in Tumor Blood Flow Assessed by Functional CT |
139 | — |
Summary
This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced neuroendocrine 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
- Patients must have histologically or cytologically confirmed low or intermediate grade carcinoid or islet cell carcinoma; patients with carcinoid or islet cell carcinoma associated with multiple endocrine neoplasia (MEN)1 syndrome will be eligible and entered in the islet cell cohort
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
- Patients may have received 0 or 1 prior cytotoxic therapy; chemotherapy used as a radiosensitizer will be considered one prior chemotherapy regimen; patient must not have received prior bevacizumab or any other therapy targeting vascular endothelial growth factor (VEGF) or VEGF receptors (i.e., SU11248, PTK787/ZK222584, Sorafenib, GW786034)
- Patients must be on a stable dose of somatostatin analogue for 2 months prior to start of protocol; octreotide dose not count toward prior therapy
- Prior radiation therapy is permitted; a recovery period of at least 4 weeks after completion of radiotherapy is required prior to enrollment
- Patients may have received prior interferon (not counted toward prior cytotoxic chemotherapy)
- Patients may have received prior therapy targeting v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (c-kit), c-abl oncogene 1, non-receptor tyrosine kinase (abl), platelet-derived growth factor receptor (PDGFR), or epidermal growth factor receptor (EGFR) (imatinib, gefitinib, erlotinib, cetuximab; not counted toward prior cytotoxic chemotherapy)
- Patients must have unresectable or metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 (Karnofsky >= 70%)
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 120,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (calculated by Cockcroft Gault formula)
- Patients must have prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 X the upper limit of normal
- Patients must have resting blood pressure (BP) no greater than 140 mmHg (systolic) or 90 mmHg (diastolic) for eligibility; initiation or adjustment of BP medication is permitted prior to study entry
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; women of child-bearing potential must have a negative blood pregnancy test prior to study entry; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
- An intrauterine device with a documented failure rate of less than 1% per year
- Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female
- Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the clinical trial, 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 interaction
- Ability to understand and the willingness to sign a written informed consent document
- Ability to swallow and retain oral medication
Exclusion Criteria
- Patients who have had chemotherapy or radiotherapy with
Data sourced from ClinicalTrials.gov (NCT00454363). 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.