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Non Small Cell Lung CancerPhase 2NCT00906282

Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

A Phase 2 study testing Pemetrexed and Carboplatin in people with Non Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 12 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this multi-center Phase II trial is to examine the impact of pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and III non-squamous NSCLC. 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 and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
12 sitesUnited States
Study dates
Jun 2009to Sep 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

  • Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
  • Life expectancy of at least 12 weeks.
  • Patients with the following stages of NSCLC:
  • T2 N0 tumors: Limited to tumors >=4 cm.
  • T1-2 N1 tumors.
  • T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving the chest wall, proximal airway, or mediastinal pleura where preoperative radiotherapy is not planned.
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  • T1-2 N2 tumors: For patients with N2 disease involving one zone (Upper zone (R), AP zone (L), subcarinal zone, or lower zone) and nodes <=2cm in diameter.
  • T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions other than malignant effusions where radiotherapy is not planned.
  • Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
  • Tumors should be considered potentially resectable.
  • No evidence of extrathoracic metastatic disease.
  • Patients must have measurable disease by RECIST criteria.
  • Patients must be candidates (medically) for chemotherapy followed by surgical resection.
  • Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery; at least 3 weeks must have elapsed from the time of a major surgery.
  • Laboratory values as follows:
  • Absolute neutrophil count (ANC) >=1500/μL
  • Hemoglobin (Hgb) >=10 g/dL
  • Platelets >=100,000/uL
  • AST/SGOT and ALT/SGPT within normal limits (WNL)
  • Total bilirubin within normal limits (WNL)
  • Calculated creatinine clearance >=45 mL/min
  • ECOG Performance Status grade 0 or 1.
  • The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.
  • 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

  • Patients with the following stages are excluded:
  • T1 N0;
  • T2 N0, with primary tumor <4 cm;
  • T1-2 N2, with multiple zones of N2 involvement;
  • T3-4 N2;
  • Any N3;
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  • Any TxNxM1 disease; or
  • Any stage where surgery and/or chemoradiotherapy is the preferred initial approach in management, as deemed by the treating physician.
  • Squamous or predominant squamous mixed histologies.
  • Mixed small-cell and non-small cell histologies.
  • Pulmonary carcinoid tumors.
  • Presence of third space fluid which cannot be controlled by drainage.
  • Use of erythropoietin as a hematopoietic growth factor is not allowed.
  • Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Women who are pregnant (positive pregnancy test) or lactating.
  • Use of any non-approved or investigational agent within 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.
  • 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.
  • History of hypersensitivity to active or inactive excipients of any component of treatment.
  • Inability to comply with study and/or follow-up procedures.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30901

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • National Capital Clinical Research Consortium

    Bethesda, Maryland, 20817

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Nebraska Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

Other trials in United States

About this study

Official title: Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

The purpose of this multi-center Phase II trial is to examine the impact of pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown to have better survival rates than patients with squamous tumors when given pemetrexed with a platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and undifferentiated), not including squamous histology, will be allowed to participate in this study. If this novel regimen proves to be safe and active in this setting, it will provide rationale for further investigation in a larger, prospective, randomized trial.

Being tested
Pemetrexed, Carboplatin
Keywords
neoadjuvant NSCLC, NSCLC, pemetrexed
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 over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).

  • CarboplatinDrug

    Also called 41575-94-4

    AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).

Study groups in NCT00906282
Study groupRoleWhat they receive
Pemetrexed/CarboplatinExperimental4 cycles of preoperative treatment (1 Cycle = 21 days): Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle; Carboplatin: AUC 6.0 by IV on Day 1 each cycle.
Receives: Drug: Pemetrexed; Drug: Carboplatin

What is being measured

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

  1. 3-Year Overall Survival Rate

    The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.

    Measured: 36 months

Secondary outcomes (4)

  1. Objective Tumor Response

    Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0. Patients with stable disease (SD) or response to treatment were deemed surgical candidates. [CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]

    Measured: At 6 and 12 weeks

  2. Pathologic Response Rate

    Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery. pCR defined as complete removal of all tumor. pPR defined as residual viable tumor demonstrated in the resected specimen.

    Measured: weeks 15 -18

  3. Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)

    pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).

    Measured: At 15-18 weeks

  4. Complete Resection Rate

    The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate. Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).

    Measured: At weeks 15-18

Timeline

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

  1. First posted21 May 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionAug 2015
  4. Study completionSep 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00906282
Sponsor's protocol ID
SCRI LUN 186
Status last verified
Jan 2017
First submitted
19 May 2009
Last updated
24 Feb 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed and Carboplatin in people with Non Small Cell Lung Cancer, run by SCRI Development Innovations, LLC at 12 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 27 inclusion and 21 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 24 Feb 2017). 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?

3-Year Overall Survival Rate (time frame: 36 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 NCT00906282.

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 24 Feb 2017.

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