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NCT Number: NCT00614965

Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV

This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Air Forces Military Hospital, Dep of Medical Oncology, Athens, Greece

Loading trial locations.

About this study

Non-platinum-based doublets including the newer drugs can be used instead of platinum-based regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed have been proven effective as second-line treatment of patients with NSCLC. In a study conducted by our group the combination of irinotecan/cisplatin demonstrated higher response rates over cisplatin monotherapy in patients progressing after first-line docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie, cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that of other platinum-based doublets. The efficacy of different platinum-based combinations in patients pretreated with non-platinum based first-line chemotherapy is not known.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed NSCLC
  • Age 18 -75 years
  • Performance status (WHO) <2
  • Patients progressing after first-line docetaxel/gemcitabine treatment
  • Adequate bone marrow (absolute neutrophil count >1000/mm3, platelet count >100000/mm3, hemoglobin > 9 gr/ mm3)
  • Adequate liver (bilirubin <1.5 times upper limit of normal), renal (Creatinine clearance > 50mg/min) and cardiac (LVEF >50%) function
  • Presence of measurable disease (according to RESIST criteria)
  • Informed consent

Exclusion criteria

  • Psychiatric illness or social situation that would preclude study compliance'
  • Other concurrent uncontrolled illness.
  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Treatment and study plan

Irinotecan

Drug

Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Other names: CPT-11

Cisplatin

Drug

Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Other names: CDDP

Pemetrexed

Drug

Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles

Other names: Alimta

Primary outcomes

  1. Overall Response Rate

    Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary outcomes

  1. Time to Tumor Progression

    Time frame: 1-year

  2. Overall Survival

    Time frame: 1-year

  3. Toxicity profile between the two treatment arms

    Time frame: Toxicity assessment on each chemotherapy cycles

  4. Quality of life assessment

    Time frame: Assessment every two cycles

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Collaborators

  • University Hospital of Crete

Registry information

Official study title

A Multicenter Randomized Phase II Study of the Combination of Irinotecan/Cisplatin Versus Pemetrexed/Cisplatin as Second-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 14, 2008
Registry last updated
May 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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