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Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Extensive Stage Small Cell Lung Cancer, Lung Metastases, Malignant Pleural Effusion, Recurrent Small Cell Lung Cancer

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Trial Information

Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 12 weeks

Outcome Description:

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients, unless we have a lost to follow-up issue. All patients meeting the eligibility criteria who have signed a consent form, begun AZD treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Julian Molina

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01831

NCT ID:

NCT00528645

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • Lung Metastases
  • Malignant Pleural Effusion
  • Recurrent Small Cell Lung Cancer
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Pleural Effusion
  • Pleural Effusion, Malignant
  • Small Cell Lung Carcinoma

Name

Location

North Central Cancer Treatment GroupRochester, Minnesota  55905