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Non Small Cell Lung CancerPhase 2ToPPSNCT00892710

Trial of Poor Performance Status Patients (ToPPS)

A Phase 2 study testing Pemetrexed, Bevacizumab and Carboplatin in people with Non Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Pemetrexed, Bevacizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
27 sitesUnited States
Study dates
Jun 2009to May 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  • Patient must be accessible for treatment and follow-up.
  • Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Who cannot join

  • 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).
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  • 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).
  • New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF) (see Appendix C).
  • Serious cardiac arrhythmia requiring medication.
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of treatment.
  • History of stroke or transient ischemic attack ≤ 6 months prior to beginning treatment.
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • History of abdominal fistula or gastrointestinal perforation ≤ 6 months prior to Day 1 of beginning treatment.
  • Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  • Use of any non-approved or investigational agent ≤ 30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  • Past or current history of neoplasm other than the entry diagnosis with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS ≥5 years.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Aventura Medical Center

    Aventura, Florida, 33180

  • Collaborative Research Group/ Palm Beach Ins of Hem Onc

    Boynton Beach, Florida, 33435

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • University of Chicago

    Chicago, Illinois, 60637

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Memorial Regional Cancer Center

    Hollywood, Florida, 33021

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Northeast Arkansas Clinic

    Jonesboro, Arkansas, 72401

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Wilshire Oncology Medical Group

    LaVerne, California, 91750

  • Family Cancer Center

    Memphis, Tennessee, 38120

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Hematology Oncology Associates of Northern NJ

    Morristown, New Jersey, 07960

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

  • Mayo Clinic - AZ

    Scottsdale, Arizona, 85259

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • RHHP/ Hope Cancer Center

    Terra Haute, Indiana, 47802

  • Toledo Community Oncology Program

    Toledo, Ohio, 43617

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

This randomized, Phase II trial will evaluate three treatment regimens in patients with previously untreated stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) and a performance status (PS) of 2. Patients will be randomized to either pemetrexed alone, pemetrexed and bevacizumab, or pemetrexed, carboplatin, and bevacizumab in a 1:1:1 fashion. All 3 regimens should be tolerable in poor performance status patients with advanced NSCLC. The 3-drug regimen (pemetrexed/carboplatin/bevacizumab) has been modified by lowering the dose of carboplatin, in order to minimize myelosuppression. This trial will be conducted at multiple study sites.

Keywords
Non small cell lung cancer, NSCLC, Pemetrexed, Bevacizumab, Avastin, Carboplatin, Stage IIIB/IV
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemetrexedDrug

    Also called Alimta

    500 mg/m2 IV given over 10 minutes every 21 days

  • BevacizumabDrug

    Also called Avastin

    15 mg/kg IV every 21 days

  • CarboplatinDrug

    Also called Paraplatin

    AUC=5 IV every 21 days

Study groups in NCT00892710
Study groupRoleWhat they receive
Pemetrexed/BevacizumabExperimental* Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days * Bevacizumab 15 mg/kg IV every 21 days
Receives: Drug: Pemetrexed; Drug: Bevacizumab
Pemetrexed/Bevacizumab/CarboplatinExperimental* 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
Receives: Drug: Pemetrexed; Drug: Bevacizumab; Drug: Carboplatin
PemetrexedExperimentalPemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
Receives: Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

Secondary outcomes (5)

  1. Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 18 months

  2. Time to Progression (TTP)

    The Length of Time, in Months, That Patients Remain 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.

    Measured: 18 months

  3. Time to Treatment Failure (TTTF)

    Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.

    Measured: 18 months

  4. Overall Survival (OS)

    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Measured: 18 months

  5. 6-month and 12-month Overall Survival Probability

    Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJul 2014
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00892710
Sponsor's protocol ID
SCRI LUN 196
Acronym
ToPPS
Status last verified
May 2015
First submitted
30 Apr 2009
Last updated
15 May 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 37419867

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed, Bevacizumab and Carboplatin in people with Non Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00892710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.

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