Trial Search Results

Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

The purpose of this study is to find out the best maintenance therapy for patients with advanced stage non-small cell lung cancer. Maintenance therapy is usually given after 4 cycles of standard chemotherapy (1 cycle = 21 days) to keep the disease under control for a longer duration. This study will compare the effects, good and/or bad, of bevacizumab, pemetrexed or the combination of the two agents when given as maintenance therapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

ECOG-ACRIN Cancer Research Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Biological: Bevacizumab
  • Drug: Pemetrexed Disodium Heptahydrate

Phase:

Phase 3

Eligibility


Inclusion Criteria (Step 1 Induction Therapy):

   - Cytologically or histologically confirmed non-small cell lung cancer (NSCLC)

   - Predominant non-squamous histology (NSCLC not otherwise specified allowed). Mixed
   tumors are categorized by the predominant cell type.

   - Stage IV disease including M1a or M1b stages or recurrent disease

   - Stage IIIB (T4NX) disease with ipsilateral lung lobe allowed provided patients are not
   candidates for combined chemotherapy or radiotherapy

   - At least 12 months since prior adjuvant chemotherapy

   - At least 2 weeks since prior radiotherapy

   - Prior carboplatin allowed provided it was given as part of adjuvant chemotherapy

   - Patients with brain metastasis must have received local therapy to the brain and have
   no evidence of progression in the brain for at least 2 weeks from the time of
   completion of local therapy, prior to registration

   - ECOG (Eastern Cooperative Oncology Group) performance status 0-1

   - Leukocytes ≥ 3,000/mm^3

   - Absolute neutrophil count ≥ 1,500/mm^3

   - Platelet count ≥ 100,000/mm^3

   - Total bilirubin ≤ institutional upper limit of normal (ULN)

   - AST and ALT ≤ 3 times ULN

   - Creatinine ≤ institutional ULN OR creatinine clearance ≥ 60 mL/min

   - Urine protein:urine dipstick ≤ 0-1+ (if > 1+, urine protein creatinine ratio must be <
   1)

   - Measurable or non-measurable disease as defined by RECIST (Response Evaluation
   Criteria in Solid Tumours) criteria

   - Patients with hypertension must be adequately controlled (BP < 150/100 mm Hg) with
   appropriate anti-hypertensive therapy or diet

   - Concurrent therapeutic anti-coagulation allowed

   - Fertile patients must agree to abstain from sexual intercourse or to use adequate
   contraceptive methods during and for at least 6 months after completion of study
   therapy

Exclusion Criteria (Step 1 Induction Therapy):

   - Prior malignancy within the past 3 years except superficial melanoma, basal cell
   carcinoma, or carcinoma in situ

   - Prior systemic chemotherapy for advanced stage lung cancer

   - Prior use of paclitaxel, pemetrexed disodium, or bevacizumab

   - Major hemoptysis within the past 4 weeks

   - Uncontrolled intercurrent illness including, but not limited to, active infection,
   symptomatic congestive heart failure, unstable angina pectoris, serious cardiac
   arrhythmia, psychiatric illness/social situations that would limit compliance with
   study requirements

   - History of arterial thrombotic events or major bleeding within the past 12 months

   - Major surgery such as thoracotomy, laparotomy, craniotomy, or significant traumatic
   injury within 6 weeks prior to registration. Biopsy procedures and chest tube
   insertion are not considered major surgery for the purpose of this protocol.

   - Core biopsy within 7 days of registration

   - Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
   recent peripheral arterial thrombosis) within the past 6 months

   - Clinically significant cardiovascular disease

   - Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the
   past 6 months

   - History of serious non-healing wounds, ulcers, or bone fractures

   - Cavitary lesions in the lungs

   - Pregnant or nursing

   - Concurrent anti-retroviral therapy in patients with HIV infection

Inclusion Criteria (Step 2 Maintenance Therapy):

   - Patient must have an overall stable or better response after 4 courses of induction
   therapy

   - ECOG (Eastern Cooperative Oncology Group) performance status 0-1

   - Patients must be registered to Step 2 within 6 weeks of the last day of chemotherapy
   administration on Step 1

   - Acceptable bone marrow, renal and hepatic function within 2 weeks of registration

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting