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