Phase II Clinical Trial of AZD2171 Monotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Tumor response (complete response [CR], partial response [PR], progressive disease [PD], and stable disease [SD]) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Study Overview
Brief Summary
This phase II trial is studying how well cediranib maleate works in treating patients with recurrent or newly diagnosed metastatic head and neck cancer. Cediranib maleate may stop the growth of head and neck cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the objective clinical response in patients with recurrent or newly diagnosed metastatic squamous cell carcinoma of the head and neck treated with AZD2171 (cediranib maleate).
SECONDARY OBJECTIVES:
I. Determine the safety profile of this drug in these patients. II. Assess the early and late physiological and biological effects of this drug on tumor interstitial fluid pressure, pO2, and tumor microvasculature.
III. Assess the value of potential noninvasive biomarkers of response, including plasma levels of molecules involved in angiogenesis, circulating endothelial cells and progenitor cells, and functional imaging changes before and after treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed squamous cell carcinoma of the head and neck meeting one of the following criteria:
- •Recurrent disease
- •Previously treated with standard curative therapy, including surgery and/or radiotherapy with or without chemotherapy
- •Newly diagnosed metastatic disease
- •Must be deemed incurable by all of the following:
- •Salvage surgery
- •Radiotherapy
- •Measurable disease ≥ 1 cm by conventional techniques, flexible fiberoptic laryngoscopy, or examination under anesthesia
- •No more than 2 prior conventional or investigational systemic therapies for categorically incurable local-regional or distant disease
- •No known primary brain tumor or brain metastases
- •ECOG performance status 0-1
- •Life expectancy ≥ 6 months
- •WBC > 3,000/mm³
- •Absolute neutrophil count > 1,500/mm³
- •Platelet count > 100,000/mm³
- •Hemoglobin > 8 g/dL
- •Bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatinine normal OR creatinine clearance > 60 mL/min
- •Proteinuria ≤ +1 on 2 consecutive urine dipsticks taken ≥ 1 week apart
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •History of nonmelanoma skin cancer or other prior malignancy allowed provided the cancer has been in remission for > 3 years
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to AZD2171
- •No hypertension (i.e., systolic blood pressure (BP) > 160 mm Hg and diastolic BP > 100 mm Hg)
- •No history of hypertensive urgency, hypertensive emergency, or end-organ damage (i.e., thrombotic stroke, transient ischemic attacks, intracerebral hemorrhage, myocardial infarction, aortic aneurysm, or aortic dissection)
- •QTc ≤ 500 msec (with Bazett's correction)
- •No history of familial long QT syndrome
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Bleeding diathesis
- •Congestive heart failure, defined as New York Heart Association (NYHA) class III-IV congestive heart failure
- •NYHA class II congestive heart failure allowed provided there is increased monitoring
- •Significant ECG abnormality
- •Peripheral vascular disease
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Pulmonary edema
- •Atrioventricular (AV) conduction abnormalities
- •Sick sinus syndrome
- •Second- or third-degree AV block
- •Deep venous thrombosis
- •No nonhealing ulcers, bone fracture, or wounds
- •No psychiatric illness or social situation that would preclude study compliance
- •No traumatic injury within the past 7 days
- •No known coagulopathy that increases risk of bleeding
- •No history of clinically significant hemorrhages
- •See Disease Characteristics
- •Recovered from all prior therapies
- •No prior antiangiogenic therapy
- +9 more not shown
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (enzyme inhibitor)
Patients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Cediranib Maleate (Drug)
Treatment (enzyme inhibitor)
Patients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Laboratory Biomarker Analysis (Other)
Outcomes
Primary Outcomes
Tumor response (complete response [CR], partial response [PR], progressive disease [PD], and stable disease [SD]) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time Frame: Baseline to day 29
Compared using logistic regression.
Secondary Outcomes
- Adverse events, graded according to the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0(Up to 28 days after last dose of study treatment)
- Distant metastasis(Every 2 courses until progression)
- Overall survival(Up to 28 days after last dose of study treatment)
- Progression-free survival(Up to 28 days after last dose of study treatment)