AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00528645
First received: September 10, 2007
Last updated: May 29, 2014
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Extensive Stage Small Cell Lung Cancer
Lung Metastases
Malignant Pleural Effusion
Recurrent Small Cell Lung Cancer
Drug: saracatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free Survival Rate at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.


Secondary Outcome Measures:
  • Survival Time [ Time Frame: From registration to death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]
    Will be estimated using the method of Kaplan-Meier.

  • Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart.

    Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.


  • Time to Disease Progression [ Time Frame: From registration to documentation of disease progression, assessed up to 2 years ] [ Designated as safety issue: No ]
    Will be estimated using the method of Kaplan-Meier.


Enrollment: 23
Study Start Date: November 2007
Study Completion Date: May 2013
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: saracatinib
Given orally
Other Name: AZD0530

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 researchinvestigation)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528645

Locations
United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Julian Molina North Central Cancer Treatment Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00528645     History of Changes
Other Study ID Numbers: NCI-2012-01831, NCI-2012-01831, NCCTG-N0621, CDR0000563952, N0621, N0621, U10CA025224
Study First Received: September 10, 2007
Results First Received: December 5, 2013
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Pleural Effusion
Pleural Effusion, Malignant
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Pleural Diseases
Pleural Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Saracatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014