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Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC

A Phase II Study of Pemetrexed and Gemcitabine Plus Bevacizumab as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer

NCT00517595•Accelerated Community Oncology Research Network

View on ClinicalTrials.gov

Summary

The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy induced toxicity profile of this combination; time to progression; and patient reported symptom burden.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient provides voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
•Patient ≥ 65 years of age with ECOG of 0 to 1
•Patient must have histologically/cytologically confirmed Stage IIIB/IV NSCLC.
•Patient has measurable disease defined as at least 1 lesion that can be accurately measured in at least 1 dimension (by CT or MRI) \& used to assess response as defined by RECIST criteria. Tumors within a previously irradiated field will be designated nontarget lesions.
•Patient has not received radiotherapy within 2 weeks(4 weeks required for brain metastases radiotherapy)of initial chemotherapy dosing for this study, and all acute toxicities due to prior radiotherapy have resolved prior to initial chemotherapy dosing.
•Patient has a negative serum pregnancy test or has undergone hysterectomy at time of enrollment.
•Greater than 12 weeks life expectancy.
•Patient has recovered from any recent surgery for at least 30 days \& is free of active infection requiring antibiotics.
•Patient must be willing/able to discontinue use of NSAIDS prior to study drug dosing.
•Patient must be able to take folic acid, Vitamin B12, \& dexamethasone per protocol.
+1 more criteria

Exclusion Criteria

•Prior systemic or other concurrent chemo for metastatic NSCLC(Prior Tarceva is not allowed).Prior adjuvant chemo acceptable as long as \> 12 months since completion and no prior pemetrexed, gemcitabine or bevacizumab.
•Lung carcinoma of squamous cell histology(mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is acceptable.Patients with extrathoracic-only squamous cell NSCLC are eligible.Patients with only peripheral lung lesions (of any NSCLC histology) will also be eligible(a peripheral lesion is defined as a lesion in which the epicenter of the tumor is ≤ 2 cm from the costal or diaphragmatic pleura in a three-dimensional orientation based on each lobe of the lung and is \> 2 cm from the trachea, main, and lobar bronchi).
•Hemoptysis within 1 month prior to study enrollment
•Ongoing treatment with full-dose warfarin or its equivalent i.e., unfractionated and/or low molecular weight heparin.(Low dose warfarin 1 mg given for prophylaxis is allowed).
•Hypersensitivity to any component of Alimta, gemcitabine \&/or bevacizumab, \&/or cannot tolerate folic acid, corticosteroids or Vitamin B12 supplements.
•Currently/have recently taken long-acting NSAID (Ibuprofen ≤ 400 mg QID acceptable) or aspirin (\>325mg/day) within 5 days of initial pemetrexed administration.
•Clinically significant pericardial/pleural effusion or ascites unless able to be drained before study entry.
•Presence of third space fluid which cannot be controlled by drainage.
•Core biopsy/other minor surgical procedure(excluding placement of a vascular access device)within 7 days prior to study enrollment.
•Active infection or fever ≥ 38.5°C within 3 days of first scheduled day of protocol treatment.
+18 more criteria

Locations (10)

Medical Oncology & Hematology

Waterbury, Connecticut, United States

Augusta Oncology Associates

Augusta, Georgia, United States

Central Georgia Cancer Care

Macon, Georgia, United States

Northwest Georgia Oncology Center

Marietta, Georgia, United States

Hematology Oncology Centers of the Northern Rockies

Billings, Montana, United States

Tri-County Oncology Hematology Associates

Canton, Ohio, United States

Pacific Oncology, PC

Portland, Oregon, United States

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, United States

The West Clinic

Memphis, Tennessee, United States

Cancer Specialists of Tidewater

Chesapeake, Virginia, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

March 12, 2012

Enrollment

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer

Interventions

Pemetrexed and Gemcitabine plus Bevacizumab

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)