AZD2171 in Treating Patients With Recurrent Small Cell Lung Cancer

NCT00245063 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02837PHII-64N01CM62201N01CM62209
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well AZD2171 works in treating patients with recurrent small cell lung cancer. AZD2171 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.

Conditions

Recurrent Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Up to 4 weeks

Study Arms (1)

Treatment (cediranib maleate)

EXPERIMENTAL

Patients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: cediranib maleate; Other: laboratory biomarker analysis; Other: pharmacogenomic studies

Interventions

cediranib maleate DRUG

Given PO

Also known as: AZD2171, Recentin

Treatment (cediranib maleate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cediranib maleate)

pharmacogenomic studies OTHER

Optional correlative studies

Also known as: Pharmacogenomic Study

Treatment (cediranib maleate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed small cell lung cancer
• 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 must have received prior platinum-based chemotherapy; no more than 1 prior chemotherapy regimen is allowed
• Life expectancy of greater than 12 weeks
• Karnofsky performance status \>= 50%
• Leukocytes \>= 3,000/mcL
• Absolute neutrophil count \>= 1,500/mcL
• Platelets \>= 100,000/mcL
• Hemoglobin \>= 8 g/dL
• Total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) =\< 2.5 × institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance \> \>= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• At present, the potential of AZD2171 for clinically significant drug interactions involving the CYP isozymes is unknown; the only documented interaction is with CYP IA agents/drugs; the other reported interactions were not seen in the dose ranges studied and appears to occur at levels far beyond what can be and will be delivered clinically; patients receiving CYP interactive concomitant medications should not be excluded from study, but those agents/drugs should be documented along with any associated AEs that occur; efforts should be made to switch patients with gliomas or brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications
• AZD2171 has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to take oral medications on a regular basis

You may not qualify if:

• Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days
• Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• Mean QTc \> 500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome
• Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart
• Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2171, breastfeeding should be discontinued if the mother is treated with AZD2171
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171
• Patients with Class III or IV heart failure (NYHA) and those requiring concurrent use of drugs with proarrhythmic potential

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cediranib; Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Limitations and Caveats

The 45 mg PO dose on arm 1 was deemed undeliverable since 7 of 12 patients were unable to complete one cycle due to treatment intolerance. Study was ammended and re-started at 30 mg (arm 2) after discussions with coinvestigators at CTEP.

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Marianna Koczywas

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: March 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 2, 2014
• Results First Posted: October 2, 2014

Record last verified: 2013-06

Locations

US (1)