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History of Changes for Study: NCT00801736
Pemetrexed and Cisplatin or Paclitaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Latest version (submitted December 9, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 2, 2008 None (earliest Version on record)
2 January 10, 2012 Recruitment Status, Arms and Interventions, Study Identification, Outcome Measures, Study Status, Sponsor/Collaborators, Contacts/Locations, Eligibility, Study Design, Study Description, Conditions and Oversight
3 December 9, 2013 Recruitment Status, Study Status, Contacts/Locations, Study Design, Eligibility and Arms and Interventions
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Study NCT00801736
Submitted Date:  December 2, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000625422
Brief Title: Pemetrexed and Cisplatin or Paclitaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title: A Multicentre, Randomised, Phase III Trial of Platinum-Based Chemotherapy Versus Non-Platinum Chemotherapy, After ERCC1 Stratification, in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Secondary IDs: CRUK-UCL-ET
EUDRACT-2007-007639-17
Open or close this module Study Status
Record Verification: December 2008
Overall Status: Not yet recruiting
Study Start: January 2009
Primary Completion: January 2012 [Anticipated]
Study Completion:
First Submitted: December 2, 2008
First Submitted that
Met QC Criteria:
December 2, 2008
First Posted: December 3, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 2, 2008
Last Update Posted: December 3, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Cancer Research UK
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether pemetrexed is more effective when given together with cisplatin or paclitaxel in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying pemetrexed to compare how well it works when given together with cisplatin or paclitaxel in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed Description:

OBJECTIVES:

Primary

  • To compare the survival of patients with ERCC1-positive or -negative stage IIIB or IV non-small cell lung cancer treated with pemetrexed disodium in combination with cisplatin vs paclitaxel.

Secondary

  • To compare the progression-free survival, response rate, and quality of life of patients treated with these regimens.
  • To investigate whether the effect of treatment differs according to histology, gender, and performance status.
  • To undertake a cost-effectiveness analysis based on the ERCC1 status of these patients.

OUTLINE: This is a multicenter study.

Patients are stratified according to disease stage (IIIB vs IV), histology (squamous vs non-squamous), smoking history (ever vs never smoker), and ERCC1 status (negative vs positive). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo quality of life assessment at baseline, prior to each course of treatment, at 21-28 days after completion of treatment, and then at 6, 12, 18, and 24 months.

After completion of study treatment, patients are followed monthly for 1 year and then every 2 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Open or close this module Conditions
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms: 2
Masking: (masked roles unspecified)
Allocation: Randomized
Enrollment: 1272 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm I
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: cisplatin
Given IV
Drug: pemetrexed disodium
Given IV
Experimental: Arm II
Patients receive pemetrexed disodium IV over 10 minutes and paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel
Given IV
Drug: pemetrexed disodium
Given IV
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Median survival time
Secondary Outcome Measures:
1. Progression-free survival
2. Overall survival
3. Time to disease progression
4. Relationship between smoking and histology and gender and histology
5. Response rate (i.e., complete response, partial response, stable disease, or progressive disease) as assessed by RECIST criteria
6. Relationship between ERCC1 status and treatment
7. Relationship between ERCC1 status and histology
8. Toxicity as assessed by NCI CTCAE v3.0
9. Quality of life as assessed by EORTC-QLQ C30, LC 13, and EuroQol EQ-5D questionnaires at baseline, prior to each course of treatment, at 21-28 days after completion of treatment, and then at 6, 12, 18, and 24 months
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC)
    • Stage IIIB (not amenable to curative treatment) or stage IV disease
  • Tissue biopsy sample must be available to determine ERCC1 status
  • At least one measurable lesion according to RECIST criteria
  • No clinically significant third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry
  • No uncontrolled brain or leptomeningeal metastases requiring immediate radiotherapy
    • Stable brain metastases allowed provided there is no evidence of disease progression on CT scan or MRI of the brain at 28 days after completion of treatment
    • Patients with incidentally discovered asymptomatic brain metastases are eligible (without having to undergo prior brain irradiation)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 8 weeks
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN (≤ 5 times ULN if liver metastases present)
  • ALT ≤ 3 times ULN
  • GFR > 50 mL/min by EDTA OR GFR > 60 mL/min by the Cockcroft and Gault formula
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Able to interrupt aspirin or other NSAID intake
  • Able and willing to take vitamin B12 and folic acid
  • No evidence of significant medical condition or laboratory finding that, in the opinion of the treating physician or chief investigator, would make it undesirable for the patient to participate in the study, including any of the following:
    • Congestive heart failure
    • Myocardial infarction within the past 6 months
    • Significant neurological or psychiatric disorder that would impact study participation
    • Infection requiring IV antibiotics
    • Tuberculosis requiring ongoing therapy
    • Superior vena cava syndrome, except if controlled with radiotherapy
    • Active peptic ulcer disease
    • Uncontrolled diabetes mellitus
    • Any contraindication to high-dose corticosteroid therapy, such as herpes simplex, herpes zoster, hepatitis, or other disease
  • No other malignant tumor except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for ≥ 3 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 28 days since prior palliative radiotherapy to non-target metastatic lesions
  • No prior chemotherapy or biological therapy for relapsed NSCLC
    • Prior surgery or radical radiotherapy allowed
  • Concurrent palliative radiotherapy allowed provided there is no evidence of disease progression
  • No concurrent yellow fever vaccine
Open or close this module Contacts/Locations
Study Officials: Siow M. Lee, MD, PhD, FRCP
Principal Investigator
Cancer Research UK
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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