Back to resultsPaclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer (PRIDE)
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paclitaxel/Carboplatin/Gefitinib
Paclitaxel/Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- More than 18 years of age
- Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
- At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
- ECOG PS 0-2
- At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
- Patients must have adequate hematologic, renal and liver function as defined by Hb > 9g/dL, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dL, and AST (SGOT) and/or ALT (SGPT) < 5 x UNL (upper normal limit).
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Written and voluntary informed consent understood, signed and dated.
Exclusion Criteria:
- Patients with tumor harboring EGFR mutation.
- Prior systemic therapy for NSCLC
- Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study.
- Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
- Major surgery within 3 weeks prior to study enrollment.
- Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
- Severe medical illness or active infection that would impair the ability to receive gefitinib.
- Pregnancy or breast feeding.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Paclitaxel/Carboplatin/Gefitinib
Paclitaxel/Carboplatin
Arm Description
Paclitaxel/Carboplatin/Gefitinib
Paclitaxel/Carboplatin
Outcomes
Primary Outcome Measures
Response Rate
Secondary Outcome Measures
progression free survival
overall survival
Full Information
NCT ID
NCT01196234
First Posted
August 9, 2010
Last Updated
January 28, 2013
Sponsor
Asan Medical Center
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT01196234
Brief Title
Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer
Acronym
PRIDE
Official Title
Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations.
Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.
Detailed Description
A randomized phase II trial that compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with NSCLC without EGFR mutations. While previous studies with cytotoxic agents and gefitinib failed to show any benefit, we altered the schedule of administration in hopes to gain synergy between agents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel/Carboplatin/Gefitinib
Arm Type
Experimental
Arm Description
Paclitaxel/Carboplatin/Gefitinib
Arm Title
Paclitaxel/Carboplatin
Arm Type
Active Comparator
Arm Description
Paclitaxel/Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel/Carboplatin/Gefitinib
Intervention Description
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15
Intervention Type
Drug
Intervention Name(s)
Paclitaxel/Carboplatin
Intervention Description
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
average 6 months
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
average 2 years
Title
overall survival
Time Frame
average 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 18 years of age
Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
ECOG PS 0-2
At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
Patients must have adequate hematologic, renal and liver function as defined by Hb > 9g/dL, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dL, and AST (SGOT) and/or ALT (SGPT) < 5 x UNL (upper normal limit).
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Written and voluntary informed consent understood, signed and dated.
Exclusion Criteria:
Patients with tumor harboring EGFR mutation.
Prior systemic therapy for NSCLC
Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study.
Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
Major surgery within 3 weeks prior to study enrollment.
Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
Severe medical illness or active infection that would impair the ability to receive gefitinib.
Pregnancy or breast feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-We Kim, MD
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
26493267
Citation
Choi YJ, Lee DH, Choi CM, Lee JS, Lee SJ, Ahn JH, Kim SW. Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naive non-small cell lung cancer in a clinically selected population excluding patients with non-smoking adenocarcinoma or mutated EGFR. BMC Cancer. 2015 Oct 22;15:763. doi: 10.1186/s12885-015-1714-y.
Results Reference
derived
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Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer
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