Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer (PRIDE)
This study has been completed.
Information provided by (Responsible Party):
Sang-We Kim, Asan Medical Center
First received: August 9, 2010
Last updated: January 28, 2013
Last verified: January 2013
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.
Non Small Cell Lung Cancer
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study
Primary Outcome Measures:
- Response Rate [ Time Frame: average 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- progression free survival [ Time Frame: average 2 years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: average 2 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2012 (Final data collection date for primary outcome measure)
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15
Active Comparator: Paclitaxel/Carboplatin
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196234
|Asan Medical Center
|Seoul, Korea, Republic of, 138-736 |
Asan Medical Center
||Sang-We Kim, MD
||Asan Medical Center
No publications provided
||Sang-We Kim, Professor, Asan Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 9, 2010
||January 28, 2013
||Korea: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors