search
Back to results

Pemetrexed With or Without Carboplatin for Elderly Non-squamous Non-small Cell Lung Cancer (ACE)

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PemCarbo
Pem only
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Elderly patients, Non-squamous Non-small Cell Lung Cancer, Pemetrexed, Carboplatin

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed advanced non-squamous non-small cell lung cancer (stage IV, AJCC 7th)
  • Age 70 years old or older
  • Eastern Cooperative Oncology Group performance status 0-1
  • Measurable or assessable disease as defined by RECIST 1.1
  • Estimated life expectancy of more than 3 months
  • Adequate bone marrow function(Absolute Neutrophil Count (ANC) ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobulin ≥ 9 g/dL)
  • Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance(Ccr) using Cockroft and Gault formula ≥45 ml/min
  • Adequate hepatic function: bilirubin < 1.5 x UNL, AST/ALT levels < 3 x UNL, alkaline phosphatase < 3 x UNL (except in case of bone metastasis without any liver disease)
  • Written informed consent

Exclusion Criteria:

  • Prior systemic chemotherapy or biological therapy
  • Contraindication to any drug contained in the chemotherapy regimen
  • Clinically significant third-space fluid collections (e.g. pleural effusion and pericardial effusion) that cannot be controlled by drainage or other procedures prior to study enrollment
  • Active infection which would compromise the patient's ability to tolerate treatment
  • Requirement for major surgery within 4 weeks of study entry
  • Myocardial infarction, uncontrolled arrhythmias, symptomatic angina pectoris, cardiac failure within the previous 6 months
  • Unable to discontinue administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); Aspirin or NSAIDs should be at least 5 days before pemetrexed administration
  • Presence or history of CNS metastasis (except if adequately treated and is not receiving steroid therapy for at least 2 weeks; at least 2 weeks for whole brain radiation or at least 1 week for gamma knife surgery)
  • Peripheral neuropathy ≥ grade 2
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin, cured carcinoma in-situ of uterine cervix and cured thyroid malignancy
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PemCarbo

Pem only

Arm Description

Pemetrexed/Carboplatin arm

Pemetrexed arm

Outcomes

Primary Outcome Measures

Progression free survival
To compare the progression free survival of elderly patients (≥70 years old) with non-squamous NSCLC receiving doublet of carboplatin and pemetrexed to patients receiving pemetrexed alone.

Secondary Outcome Measures

Objective response rate, Overall survival, Safety and Quality of life
To compare the following efficacy variables between treatment arms: Objective response rate Overall survival To compare the safety and adverse event profile between treatment arms To assess the impact of treatment on patient-rated quality of life (FACT-L)

Full Information

First Posted
January 11, 2012
Last Updated
May 5, 2012
Sponsor
Asan Medical Center
Collaborators
Eli Lilly and Company, Korean Cancer Study Group
search

1. Study Identification

Unique Protocol Identification Number
NCT01593293
Brief Title
Pemetrexed With or Without Carboplatin for Elderly Non-squamous Non-small Cell Lung Cancer
Acronym
ACE
Official Title
A Randomized, Open-label, Phase III Study Comparing Pemetrexed With and Without Carboplatin in Elderly Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Eli Lilly and Company, Korean Cancer Study Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy in terms disease progression, overall survival, and quality of life and tolerability.
Detailed Description
The treatment of NSCLC in elderly has been subject to discussion for years. While platinum doublets consisting of cisplatin or carboplatin and another cytotoxic agent demonstrate a survival advantage compared with single agents generally, evidence of treatment efficacy for patients with diminished performance status (PS) or with age older than 70 years is limited. Guidelines from the US and Europe have preferred single-agent chemotherapy for the elderly and PS 2 patients. However, increasing studies are exploring this issue and presenting data that favour doublet therapy. The addition of carboplatin to paclitaxel and cisplatin to docetaxel have shown evidence that patients over 70 benefit more in face of increased toxicities. This study is designed to be multi-center, open-label, prospective, randomized, two-arm, parallel, phase III trial of elderly patients(≥70 years old) with metastatic non-squamous NSCLC (Stage IV by AJCC 7th) who have not received prior systemic chemotherapy or biological therapy. Approximately 266 patients will be enrolled into the trial. This study compares the doublet therapy of pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL*min) administered intravenously every 21 days for 4 cycles followed by pemetrexed (500 mg/m2) every 21 days for maintenance therapy (Arm A) to single therapy of pemetrexed (500 mg/m2) every 21 days till progression or unacceptable toxicity (Arm B). Pemetrexed will be administered with vitamin B12 and folate supplements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Elderly patients, Non-squamous Non-small Cell Lung Cancer, Pemetrexed, Carboplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PemCarbo
Arm Type
Active Comparator
Arm Description
Pemetrexed/Carboplatin arm
Arm Title
Pem only
Arm Type
Active Comparator
Arm Description
Pemetrexed arm
Intervention Type
Drug
Intervention Name(s)
PemCarbo
Other Intervention Name(s)
Alimta: brand name of Pemetrexed
Intervention Description
Pemetrexed 500mg/m2, Carboplatin AUC5 intravenously q 3 weeks for 4 cycles, followed by pemtrexed 500mg/m2 q 3 weeks for maintenance therapy
Intervention Type
Drug
Intervention Name(s)
Pem only
Other Intervention Name(s)
Alimta: brand name of pemetrexed
Intervention Description
Pemetrexed 500mg/m2 intrvenously q 3 weeks till progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Progression free survival
Description
To compare the progression free survival of elderly patients (≥70 years old) with non-squamous NSCLC receiving doublet of carboplatin and pemetrexed to patients receiving pemetrexed alone.
Time Frame
The study lasts for 30 months of which subject accrual occurs in the first 24 months
Secondary Outcome Measure Information:
Title
Objective response rate, Overall survival, Safety and Quality of life
Description
To compare the following efficacy variables between treatment arms: Objective response rate Overall survival To compare the safety and adverse event profile between treatment arms To assess the impact of treatment on patient-rated quality of life (FACT-L)
Time Frame
The study lasts for 30 months of which subject accrual occurs in the first 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed advanced non-squamous non-small cell lung cancer (stage IV, AJCC 7th) Age 70 years old or older Eastern Cooperative Oncology Group performance status 0-1 Measurable or assessable disease as defined by RECIST 1.1 Estimated life expectancy of more than 3 months Adequate bone marrow function(Absolute Neutrophil Count (ANC) ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobulin ≥ 9 g/dL) Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine clearance(Ccr) using Cockroft and Gault formula ≥45 ml/min Adequate hepatic function: bilirubin < 1.5 x UNL, AST/ALT levels < 3 x UNL, alkaline phosphatase < 3 x UNL (except in case of bone metastasis without any liver disease) Written informed consent Exclusion Criteria: Prior systemic chemotherapy or biological therapy Contraindication to any drug contained in the chemotherapy regimen Clinically significant third-space fluid collections (e.g. pleural effusion and pericardial effusion) that cannot be controlled by drainage or other procedures prior to study enrollment Active infection which would compromise the patient's ability to tolerate treatment Requirement for major surgery within 4 weeks of study entry Myocardial infarction, uncontrolled arrhythmias, symptomatic angina pectoris, cardiac failure within the previous 6 months Unable to discontinue administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); Aspirin or NSAIDs should be at least 5 days before pemetrexed administration Presence or history of CNS metastasis (except if adequately treated and is not receiving steroid therapy for at least 2 weeks; at least 2 weeks for whole brain radiation or at least 1 week for gamma knife surgery) Peripheral neuropathy ≥ grade 2 History of another malignancy within the last five years except cured basal cell carcinoma of skin, cured carcinoma in-situ of uterine cervix and cured thyroid malignancy Pregnant or lactating women, women of childbearing potential not employing adequate contraception Other serious illness or medical conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang-We Kim, M.D.
Phone
82-2-3010-3215
Email
swkim@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-We Kim, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-We Kim, M.D.
Phone
82-2-3010-3215
Email
swkim@amc.seoul.kr

12. IPD Sharing Statement

Learn more about this trial

Pemetrexed With or Without Carboplatin for Elderly Non-squamous Non-small Cell Lung Cancer

We'll reach out to this number within 24 hrs