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

January 28, 2013 updated by: Sang-We Kim, Asan Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Paclitaxel/Carboplatin
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: average 6 months
average 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: average 2 years
average 2 years
overall survival
Time Frame: average 2 years
average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Sang-We Kim, MD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC 2009-0677

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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