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A Study of Pemetrexed and Cisplatin, in Non Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000480
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : January 1, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 21, 2009
First Posted Date  ICMJE October 23, 2009
Results First Submitted Date  ICMJE November 12, 2013
Results First Posted Date  ICMJE January 1, 2014
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
1 Year Progression Free Survival [ Time Frame: Date of first dose to date of objectively determined PD or death [every cycle up to 4 cycles and then every 3 months up to 1 year (1 cycle=21 days)] ]
Progression free survival (PFS) was defined as the time from study enrollment to the first observation of progressive disease (PD) or death from any cause. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study drug) prior to objectively determined PD or death, PFS was censored at the date of the last objective progression-free disease assessment prior to start of postdiscontinuation chemotherapy. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
1 Year Progression Free Survival [ Time Frame: from the time of study enrollment to the first date of objectively determined PD or death from any cause (every cycle up to 4 cycles and then every 3 months up to 1 year after enrollment) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
  • Overall Survival [ Time Frame: Date of first dose to date of death (up to 35.4 months) ]
    Overall survival (OS) was the duration from enrollment to death due to any cause. Participants who were alive were censored at the last contact.
  • Number of Participants With an Objective Tumor Response [ Time Frame: Date of first dose through end of follow-up [up to 30 weeks (1 cycle=21 days)] ]
    Participants with confirmed complete response (CR), confirmed partial response (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria, as well as participants with a not evaluable/tumor response unknown. CR: disappearance of all tumor lesions. PR: either a) at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as a reference baseline sum LDs, or b) complete disappearance of target lesions, with persistence (not worsening) of 1 or more nontarget lesions. In either case, no new lesions appeared. SD: small changes that did not meet above criteria. PD: at least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
  • Overall Survival [ Time Frame: from enrollment until the date of death from any cause (every cycle up to 4 cycles and then every 3 months up to 1 year and then every 6 months up to 2 years after enrollment) ]
  • Number of patients with an objective tumor response [ Time Frame: from enrollment until the end of chemoradiation (up to 30 weeks after enrolment) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pemetrexed and Cisplatin, in Non Small Cell Lung Cancer
Official Title  ICMJE Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin With Concurrent Thoracic Radiotherapy, in Patients With Unresectable, Locally Advanced, Stage III, Nonsquamous Non-Small Cell Lung Cancer
Brief Summary This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in combination with radiotherapy in participants with locally advanced, non-small cell lung cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by progression free survival 1 year after start of treatment with study drug.
Detailed Description The participants will receive 2 cycles of pemetrexed and cisplatin. If the participants achieve complete response, partial response or stable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, have ≤35% of the total calculated lung volume receive more than 20 Gy (V20) according to the 3-dimensional (3-D) radiotherapy planning Dose Volume Histograms, have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, have no residual neurological toxicity > Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), they will receive 2 additional cycles of pemetrexed and cisplatin, combined with radiotherapy. The combination of radiotherapy will begin 22 to 36 days after completion of the second infusion of induction therapy with pemetrexed-cisplatin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Pemetrexed
    500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of a 21 day cycle for 2 cycles: with possibility of 2 additional cycles.
    Other Names:
    • Alimta
    • LY231514
  • Drug: Cisplatin
    75 mg/m² intravenous infusion on Day 1 of a 21 day cycle for 2 cycles; with the possibility of 2 additional cycles.
  • Radiation: Thoracic Radiotherapy
    Administered at 2 gray (Gy)/fraction after completion of the pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and will continue daily (5 days per week) until the total delivered dose reaches a therapeutic goal of 66 Gy, over approximately 7 weeks.
Study Arms  ICMJE Experimental: Pemetrexed
Pemetrexed and cisplatin are given as induction therapy followed after by pemetrexed and cisplatin with concurrent radiotherapy.
Interventions:
  • Drug: Pemetrexed
  • Drug: Cisplatin
  • Radiation: Thoracic Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2013)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
88
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologic or cytologic diagnosis of unresectable nonsquamous Stage IIIA or Stage IIIB (without malignant pleural/pericardial effusions) NSCLC.
  • Have an ECOG performance status of 0 or 1.
  • Previous radiation therapy should have been limited and must not have included thoracic radiation, whole pelvis radiation, or radiation to >25% of the participant's bone marrow, participants must have recovered from the toxic effects of radiation treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry.
  • Have at least 1 unidimensionally measurable lesion meeting RECIST guidelines, version 1.0.
  • Estimated life expectancy of at least 12 weeks.
  • Participant compliance and geographic proximity that allow adequate follow-up.
  • Adequate bone marrow reserve, hepatic-, renal- and pulmonary function.
  • Participants must sign an Informed Consent Document.
  • Participants must have a total lung V20 less than or equal to 35%.
  • For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen, during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
  • Have not received prior systemic anticancer therapy for NSCLC.

Exclusion Criteria:

  • Have received treatment within the last 30 days of enrollment with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Have previously completed or withdrawn from this study or any other study investigating pemetrexed.
  • Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
  • Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
  • Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Participants with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
  • Are receiving concurrent administration of any other antitumor therapy.
  • Have had weight loss of more than 10% over the previous 3 months before study entry.
  • Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose less than or equal to 1.3 grams per day, for at least 2 days before (5 days for long-acting agents), the day of, and for at least 2 days after administration of pemetrexed.
  • Are unable or unwilling to take folic acid or vitamin B12 supplementation.
  • Are unable or unwilling to take corticosteroids.
  • Have received a recent yellow fever vaccination (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination.
  • Have known hypersensitivity to pemetrexed, cisplatin, or any of the excipients in these medicinal products.
  • Have evidence of clinical hearing loss.
  • Have clinically significant third-space fluid collections, that cannot be controlled by drainage or other procedures prior to study entry.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000480
Other Study ID Numbers  ICMJE 13099
H3E-EW-S128 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT- 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP