Non Small Cell Lung Cancer Clinical Trial
— PRIDEOfficial title:
Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study
Verified date | January 2013 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | December 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center | AstraZeneca |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | average 6 months | No | |
Secondary | progression free survival | average 2 years | No | |
Secondary | overall survival | average 2 years | No |
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