Trial of Poor Performance Status Patients (ToPPS)
ToPPS
Randomized Phase II Trial of Pemetrexed vs. Pemetrexed/Bevacizumab vs. Pemetrexed/Carboplatin/Bevacizumab in Patients With Stage IIIB/IV Non-Small-Cell Lung Cancer and ECOG Performance Status 2
1 other identifier
interventional
172
1 country
27
Brief Summary
The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2009
CompletedFirst Posted
Study publicly available on registry
May 4, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
May 15, 2015
CompletedMay 15, 2015
May 1, 2015
5.1 years
April 30, 2009
April 24, 2015
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
18 months
Secondary Outcomes (5)
Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment
18 months
Time to Progression (TTP)
18 months
Time to Treatment Failure (TTTF)
18 months
Overall Survival (OS)
18 months
6-month and 12-month Overall Survival Probability
12 months
Study Arms (3)
Pemetrexed/Bevacizumab
EXPERIMENTAL* Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days * Bevacizumab 15 mg/kg IV every 21 days
Pemetrexed/Bevacizumab/Carboplatin
EXPERIMENTAL* Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days * Bevacizumab 15 mg/kg IV every 21 days * Carboplatin AUC=5 IV every 21 days
Pemetrexed
EXPERIMENTALPemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
Interventions
500 mg/m2 IV given over 10 minutes every 21 days
15 mg/kg IV every 21 days
Eligibility Criteria
You may qualify if:
- Patients must be \>=18 years of age.
- Non-squamous NSCLC (adenocarcinoma or large cell carcinoma). Mixed tumors with small cell anaplastic elements are not eligible. Mixed tumors with squamous histology are acceptable as long as the squamous element is not the dominant histology.
- Unresectable stage IIIB or stage IV disease. Stage IIIB disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions).
- ECOG performance status of 2.
- No prior systemic therapy for stage IIIB or stage IV lung cancer.
- Life expectancy of at least 12 weeks.
- Patients must have measurable disease per RECIST version 1.1 (see Section 8).
- Laboratory values as follows:
- Absolute neutrophil count (ANC) ≥1500/μL
- Hemoglobin (Hgb) ≥10 g/dL
- Platelets ≥100,000/μL (≤7 days prior to treatment)
- AST or ALT and alkaline phosphatase (ALP) must be \<2.5 x ULN, or \<5 x ULN in patients with liver metastases.
- Total bilirubin \<1.5 x the institutional ULN
- Calculated creatinine clearance ≥45 mL/min
- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
- +3 more criteria
You may not qualify if:
- Squamous cell histology. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient will be ineligible; sputum cytology alone is unacceptable.
- Patients with active brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if there is no evidence of central nervous system (CNS) disease progression, and at least 2 weeks have elapsed since treatment. Ideally, patients should not still require use of seizure medication or steroids.
- Patients who have had major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 4 weeks of beginning treatment; or, the anticipation of the need for major surgical procedure during the course of the study.
- Women who are pregnant or lactating.
- Minor surgical procedures (with the exception of the placement of portacath or other central venous access) must be completed at least 7 days prior to beginning protocol treatment.
- History of hypersensitivity to active or inactive excipients of any component of treatment (pemetrexed, bevacizumab, and/or carboplatin).
- Pulmonary carcinoid tumors.
- Patients with proteinuria at screening as demonstrated by either:
- urine protein creatinine (UPC) ratio ≥1.0 at screening OR
- urine dipstick for proteinuria ≥2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection, and must demonstrate ≤1 g of protein/24 hours to be eligible) (see Appendix B)
- Patients with a serious non healing wound, active ulcer, or untreated bone fracture.
- Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) within 1 month prior to study enrollment.
- History of myocardial infarction or unstable angina within 6 months of beginning treatment.
- Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and /or diastolic blood pressure \>100 mmHg while on antihypertensive medications).
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
Study Sites (27)
Mayo Clinic - AZ
Scottsdale, Arizona, 85259, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Wilshire Oncology Medical Group
LaVerne, California, 91750, United States
Aventura Medical Center
Aventura, Florida, 33180, United States
Collaborative Research Group/ Palm Beach Ins of Hem Onc
Boynton Beach, Florida, 33435, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Memorial Regional Cancer Center
Hollywood, Florida, 33021, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
University of Chicago
Chicago, Illinois, 60637, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
RHHP/ Hope Cancer Center
Terra Haute, Indiana, 47802, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, 07960, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Toledo Community Oncology Program
Toledo, Ohio, 43617, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Family Cancer Center
Memphis, Tennessee, 38120, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Virginia Cancer Institute
Richmond, Virginia, 23235, United States
Related Publications (1)
Gijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2.
PMID: 37419867DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- STUDY CHAIR
David Spigel, M.D.
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2009
First Posted
May 4, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2014
Study Completion
May 1, 2015
Last Updated
May 15, 2015
Results First Posted
May 15, 2015
Record last verified: 2015-05