AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer

NCT ID: NCT00528645

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2013-05-31

Brief Summary

AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II study is studying how well giving AZD0530 works in treating patients with extensive-stage small cell lung cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the 12-week progression-free survival rate of patients with extensive stage small cell lung cancer treated with AZD0530.

SECONDARY OBJECTIVES:

I. To determine the response rate in patients treated with this drug. II. To determine the overall survival and time-to-progression in patients treated with this drug.

III. To determine the adverse events of AZD0530 in these patients IV. To determine the effect of AZD0530 treatment on levels of circulating tumor cells in these patients.

V. To determine potential predictive markers of response in circulating tumor cells after treatment with this drug.

VI. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in patients treated with this drug.

TERTIARY OBJECTIVES:

I. To determine the effect of AZD0530 treatment on levels of circulating tumor cells.

II. To determine potential predictive markers of response in circulating tumor cells after treatment with this drug.

III. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in patients treated with this drug.

OUTLINE: Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.

After completion of study therapy, patients are followed periodically for up to 2 years.

Conditions

Extensive Stage Small Cell Lung Cancer; Lung Metastases; Malignant Pleural Effusion; Recurrent Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (saracatinib)

Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.

Group Type: EXPERIMENTAL

saracatinib

Intervention Type: DRUG

Given orally

Interventions

saracatinib

Given orally

Intervention Type: DRUG

Other Intervention Names

AZD0530

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed small cell lung cancer

• No mixed histology
• Extensive stage disease, defined as any of the following:

• Metastatic disease outside the chest
• Contralateral supraclavicular nodes or contralateral hilar nodes that cannot be included in a single radiation port
• Cytologically confirmed malignant pleural effusion

• Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
• Previously untreated disease* OR stable disease, partial response, or complete response ≤ 4 weeks after completion of one course (four 3-week courses) of standard platinum-based chemotherapy
• No symptomatic, untreated, or uncontrolled CNS metastases

• CNS metastases previously treated with whole brain radiotherapy allowed
• ECOG performance status (PS) 0-2
• Life expectancy ≥ 12 weeks
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin > 9.0 g/dL
• Total bilirubin < 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 times ULN
• ALT and AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Proteinuria ≤ +1 on two consecutive dipsticks taken no less than 24hours apart
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective protection during and for up to 8 weeks after completion of study therapy
• QTc interval ≤ 460 msec
• No seizure disorder
• No significant traumatic injury ≤ 4 weeks prior to registration
• No clinically significant infection
• No HIV-positivity
• No second primary malignancy, except for carcinoma in situ of the cervix or nonmelanoma skin cancer, unless prior malignancy was diagnosed and treated ≥ 5 years with no subsequent evidence of recurrence

• Patients with a history of low grade(Gleason score ≤ 6) localized prostate cancer will be eligible even if diagnosed < 5 years prior to registration
• No concurrent severe and/or uncontrolled medical conditions, including any of the following:

• Cardiac arrhythmias
• Angina pectoris uncontrolled with medication
• Myocardial infarction within the past 3 months
• Significant ECG abnormalities
• Hypertension, labile hypertension, or history of poor compliance with anti-hypertensive medication
• Congestive heart failure within the past 3 months, unless ejection fraction > 40%
• Interstitial pneumonia or extensive, symptomatic interstitial fibrosis of the lung
• Poorly controlled diabetes
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
• No condition that impairs the ability to swallow AZD0530 tablets, including any of the following:

• Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
• Prior surgical procedures affecting absorption of AZD0530 tablets
• Active peptic ulcer disease
• No serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study
• At least 4 weeks since prior major surgery (i.e., laparotomy) or open biopsy
• At least 2 weeks since prior minor surgery
• At least 4 weeks since any prior investigational ancillary therapy (i.e., utilized for a non-FDA-approved indication and in the context of a research investigation)
• At least 7 days since prior use of strong inhibitors of CYP3A4 and no concurrent use for up to 7 days after discontinuation of AZD0530
• Prior nonthoracic palliative radiotherapy allowed
• Concurrent bisphosphonates for treatment of lytic metastatic bone disease allowed at the discretion of the treating physician
• No concurrent prophylactic granulocyte colony-stimulating factor (i.e., G-CSF)
• No concurrent products that stimulate thrombopoiesis
• No concurrent St. John's wort
• No other concurrent chemotherapy, immunotherapy, hormonal therapy,or radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Molina

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

North Central Cancer Treatment Group

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

NCI-2012-01831

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-N0621

Identifier Type: -

Identifier Source: secondary_id

CDR0000563952

Identifier Type: -

Identifier Source: secondary_id

N0621

Identifier Type: OTHER

Identifier Source: secondary_id

N0621

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA025224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01831

Identifier Type: -

Identifier Source: org_study_id