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Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer (PRIDE)

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ClinicalTrials.gov Identifier: NCT01196234
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : January 29, 2013
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Sang-We Kim, Asan Medical Center

August 9, 2010
September 8, 2010
January 29, 2013
December 2009
February 2012   (Final data collection date for primary outcome measure)
Response Rate [ Time Frame: average 6 months ]
Same as current
Complete list of historical versions of study NCT01196234 on ClinicalTrials.gov Archive Site
  • progression free survival [ Time Frame: average 2 years ]
  • overall survival [ Time Frame: average 2 years ]
Same as current
Not Provided
Not Provided
 
Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer
Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study

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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: Paclitaxel/Carboplatin/Gefitinib
    paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15
  • Drug: Paclitaxel/Carboplatin
    paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)
  • Experimental: Paclitaxel/Carboplatin/Gefitinib
    Paclitaxel/Carboplatin/Gefitinib
    Intervention: Drug: Paclitaxel/Carboplatin/Gefitinib
  • Active Comparator: Paclitaxel/Carboplatin
    Paclitaxel/Carboplatin
    Intervention: Drug: Paclitaxel/Carboplatin
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-naïve 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
Same as current
December 2012
February 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01196234
AMC 2009-0677
No
Not Provided
Not Provided
Sang-We Kim, Asan Medical Center
Asan Medical Center
AstraZeneca
Principal Investigator: Sang-We Kim, MD Asan Medical Center
Asan Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP