Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers

NCT01502202 | Unknown Phase 2

• 1 other identifier: NCCCTS-11-581
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Intercalated administration of Iressa® (gefitinib) on days 5-18 of chemotherapy cycle improve the efficacy of Pemetrexed/platinum regimen given as first-line treatment for never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.

Conditions

Non Small Cell Lung Cancer; Adenocarcinoma

Keywords

lung adenocarcinoma; never smoker; 1st line treatment; Intercalation administration; Gefitinib; never smokers

Outcome Measures

Primary Outcomes (1)

• To compare progression-free survival

  from date of randomization until the date of first documented progression or death from any case. Assessed minimum 1 years.

  minimum 1-year follow-up

Secondary Outcomes (6)

• To compare objective response rate (CR+PR)

  minimum 1-year follow-up

• To compare duration of response.

  minimum 1-year follow-up

• To compare non progression rate (CR+PR+SD) at 16 weeks.

  at 16 weeks

• To compare overall survival.

  minimum 1-year follow-up

• To compare number of Grade 3/4 Adverse Events

  average up to 1 year

Study Arms (2)

Study arm

ACTIVE COMPARATOR

Pemetrexed plus Cisplatin plus Gefitinib

Drug: Gefitinib; Drug: Pemetrexed plusCIsplatin

Placebo arm

PLACEBO COMPARATOR

Pemetrexed plus Cisplatin plus Placebo

Drug: Placebo; Drug: Pemetrexed plusCIsplatin

Interventions

Gefitinib DRUG

Gefitinib 250mg, per PO. daily, D 5-18 (during 14 days)

Also known as: AP-G

Study arm

Placebo DRUG

Placebo 1 tablet, per PO, Daily on D 5-18 (during 14 days)

Also known as: AP-P

Placebo arm

Pemetrexed plusCIsplatin DRUG

Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles

Also known as: Standard chemotherapy

Placebo arm; Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of adenocarcinoma of lung with or without BAC features; however, adenocarcinoma combined with other histology, such as small cell carcinoma or squamous carcinoma, is not allowed.
• Stage IIIB (not amenable for radical loco-regional therapy) or stage IV (metastatic) patients according to the 7th TNM staging system
• Age 18-75
• Never-smoking defined as not more than 100 cigarettes during the lifetime
• ECOG performance status of 0-2
• Good organ function
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. The only approved consent form is attached to this protocol

You may not qualify if:

• Patients with prior exposure to agents directed at the HER
• Patients with prior chemotherapy or therapy with systemic anti-tumour therapy for advanced disease.
• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
• Known severe hypersensitivity to gefitinib or to any of the study drugs.
• Any evidence of clinically active interstitial lung disease
• Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
• Prior invasive malignancies 3 years prior to study entry except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• Pregnancy or breast-feeding (women of child-bearing potential).
• Sexually active males and females (of childbearing potential) unwilling to practice acceptable methods of birth control

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• AstraZeneca: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyenggido, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Adenocarcinoma of Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jin Soo Lee, M.D. PhD.

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Soo Lee, M.D. PhD.

CONTACT

+82-31-920-1501; jslee@ncc.re.kr

SUNG JIN YOON, RN

CONTACT

+82-31-920-0405; jinijiniya@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 30, 2011
• Study Start: March 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2015
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

KR (1)