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A Phase II Trial of Pemetrexed, Gemcitabine, and Bevacizumab Every Two Weeks in Chemotherapy-Naive Patients With Stages IIIB/IV Non- Squamous, Non-Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Phase II Trial of Pemetrexed, Gemcitabine, and Bevacizumab Every Two Weeks in Chemotherapy-Naive Patients With Stages IIIB/IV Non- Squamous, Non-Small Cell Lung Cancer (NSCLC)


OBJECTIVES:

Primary

- Determine the efficacy of pemetrexed disodium, gemcitabine hydrochloride, and
bevacizumab in chemotherapy-naïve patients with stage IIIB or IV nonsquamous cell
non-small cell lung cancer.

Secondary

- Determine the response rate in patients treated with this regimen.

- Determine the time to treatment failure in patients treated with this regimen.

- Determine the overall survival of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes, gemcitabine hydrochloride
IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every
14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients may then receive bevacizumab alone in the absence of disease progression or
unacceptable toxicity.

After the completion of study treatment, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed nonsquamous cell non-small cell lung cancer
(NSCLC), including the following cell types:

- Adenocarcinoma

- Bronchoalveolar

- Large cell carcinoma

- Stage IIIB or IV NSCLC

- Patients with stage IIIB disease must have a pleural effusion OR not be a
candidate for chemoradiotherapy as treatment for locally advanced disease

- Unidimensionally measurable or evaluable disease

- Disease in a prior radiation port must have documented progression

- No tumor with cavitation or close proximity to a major vessel

- No CNS or untreated brain metastases

- Treated brain metastases allowed provided there is no evidence of progression or
hemorrhage after treatment and no ongoing requirement for dexamethasone, as
determined by clinical examination and brain imaging (MRI or CT) during the
screening period

- Treatment for brain metastases may include whole brain radiotherapy,
radiosurgery (i.e., Gamma Knife, LINAC, or equivalent) or a combination as
deemed appropriate by the treating physician

- Stable-dose anticonvulsants allowed

- Patients with CNS metastases treated by neurosurgical resection or brain biopsy
performed within 3 months prior to Day 1 are not allowed

- No clinically significant effusion that cannot be drained

- No disease that cannot be radiologically imaged

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy > 12 weeks

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin > 8 g/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

- AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

- Creatinine clearance ≥ 45 mL/min

- Urine protein:creatinine ratio ≤ 1.0

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- No significant cardiovascular illness, including any of the following:

- Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)

- Myocardial infarction within the past 6 months

- Unstable angina

- Hemorrhagic or thrombotic stroke or other CNS bleeding within the past 6 months

- Clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- New York Heart Association class II-IV congestive heart failure

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months

- No significant traumatic injury within the past 28 days

- No serious, nonhealing wound, ulcer, or bone fracture

- No hemoptysis > grade 2 within the past 28 days

- No hematemesis > grade 2 within the past 6 months OR grade 1 hematemesis within the
past 28 days

- No inability to take dexamethasone, folic acid, or cyanocobalamin (vitamin B12)

- No other serious systemic disorder (including oncologic emergencies) incompatible
with study treatment

- No other malignancy within the past 3 years except for adequately treated squamous
cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 1 week since prior minor surgical procedure, such as fine-needle aspiration
or core biopsy

- At least 4 weeks since prior and no concurrent major surgery or open biopsy

- At least 4 weeks since prior radiotherapy

- At least 4 weeks since prior and no concurrent participation in another experimental
drug study other than a Genentech-sponsored bevacizumab cancer study

- No prior chemotherapy

- No concurrent stimulators of thrombopoiesis

- No concurrent full-dose anticoagulants

- No nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, during, and 2 days
after pemetrexed disodium administration (5 days before for NSAIDs [including
cyclooxygenase-2 inhibitors] with a long half-life [e.g., naproxen, piroxicam,
diflunisal, nabumetone, rofecoxib, or celecoxib])

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

Outcome Description:

Progression-free survival will be defined as the time from the first day of treatment until the date that progressive disease (PD), symptomatic deterioration, or death due to any cause is first reported. Patients who die without reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress will be censored at the day of last tumor assessment.

Outcome Time Frame:

Change in tumor size from baseline beginning with cycle 4 then every 4 cycles thereafter.

Safety Issue:

No

Principal Investigator

Antoinette J. Wozniak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000531832

NCT ID:

NCT00438204

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201