Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AZD...

Detailed Description

OBJECTIVES: Primary * Assess the objective tumor response rate in patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride, carboplatin, and AZD2171 as first-...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Squamous cell histology allowed
  • No mixed histology with small cell component
  • Stage IIIB (with pleural effusion) or stage IV disease
  • Presence of peritoneal or pericardial effusion alone in the absence of cytologic evidence is not allowed
  • Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
  • If the only site of measurable disease was previously irradiated, progressive disease must be evident
  • Ineligible for bevacizumab therapy
  • No symptomatic, untreated, or uncontrolled CNS metastases
  • CNS metastases treated with whole-brain radiation (WBRT) allowed 4 weeks after completion of WBRT
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • ALT and AST ≤ 3 times ULN (5 times ULN if liver involvement)
  • Alkaline phosphatase ≤ 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No proteinuria ≥ 1+
  • No uncontrolled blood pressure (BP), defined as systolic BP \> 150 mm Hg and/or diastolic BP \> 100 mm Hg in spite of adequate antihypertensive therapy
  • No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD2171 (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or small bowel resection)
  • No seizure disorder
  • No significant traumatic injury within 4 weeks prior to study entry
  • No second primary malignancy except any of the following:
  • Carcinoma in situ of the cervix
  • Nonmelanoma skin cancer
  • Prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
  • History of low-grade (Gleason score ≤ 6) localized prostate cancer even if diagnosed \< 5 years prior to registration
  • Treated stage I breast cancer ≤ 5 years prior to registration
  • No uncontrolled intercurrent illness, including, but not limited to, any of the following:
  • Ongoing or active infection
  • Significant pulmonary symptoms at baseline due to disease
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situation that would limit compliance with study requirements
  • Baseline hemoptysis
  • Cavitating lesions
  • No QTc prolongation \> 500 msec or other significant ECG abnormality within the past 14 days
  • No New York Heart Association class III or IV disease
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior chemotherapy for advanced lung cancer
  • Neoadjuvant or adjuvant therapy for lung cancer within the past 12 months allowed
  • More than 12 months since prior immunotherapy and biologic therapy
  • More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases)
  • At least 2 weeks since prior WBRT
  • No radiotherapy to ≥ 25% of bone marrow
  • No major surgery (i.e., laparotomy) or open biopsy within 4 weeks prior to study entry (2 weeks for minor surgery)
  • Insertion of a vascular access device not considered major or minor surgery
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent grapefruit or grapefruit juice during AZD2171 treatment
  • No concurrent drugs or biologics with proarrhythmic potential
  • Concurrent palliative radiotherapy to nontarget sites (i.e., painful pre-existing bony metastasis) allowed with AZD2171 (chemotherapy is held until completion of radiotherapy)

Exclusion

    Key Trial Info

    Start Date :

    June 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2010

    Estimated Enrollment :

    101 Patients enrolled

    Trial Details

    Trial ID

    NCT00326599

    Start Date

    June 1 2007

    End Date

    February 1 2010

    Last Update

    March 21 2017

    Active Locations (154)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 39 (154 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    3

    Rush-Copley Cancer Care Center

    Aurora, Illinois, United States, 60504

    4

    St. Joseph Medical Center

    Bloomington, Illinois, United States, 61701