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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Sang-We Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01196234
First received: August 9, 2010
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
 Drug: Paclitaxel/Carboplatin/Gefitinib
Drug: Paclitaxel/Carboplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Asan Medical Center:

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 ]

Enrollment: 84
Study Start Date: December 2009
Study Completion Date: December 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel/Carboplatin/Gefitinib
Paclitaxel/Carboplatin/Gefitinib
 Drug: Paclitaxel/Carboplatin/Gefitinib
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/Carboplatin
 Drug: Paclitaxel/Carboplatin
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196234

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
AstraZeneca
Investigators
Principal Investigator: Sang-We Kim, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Sang-We Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01196234     History of Changes
Other Study ID Numbers: AMC 2009-0677
Study First Received: August 9, 2010
Last Updated: January 28, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Carboplatin
 Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013