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Chemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation (INNOVATE)

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ClinicalTrials.gov Identifier: NCT02095782
Recruitment Status : Terminated (Because of the very slow enrollment, this study was stopped.)
First Posted : March 26, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Guangdong Association of Clinical Trials

Brief Summary:
This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of intercalated combination of doublet chemotherapy of paclitaxel plus carboplatin and erlotinib on patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: Intercalated combination of chemotherapy and erlotinib Phase 2

Detailed Description:

Primary therapy stage:

Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.

Maintenance therapy stage:

Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intercalated Combination of Chemotherapy and Erlotinib in 1st Line Setting for Patients Advanced Stage Non-small-cell Lung Cancer With Low Abundant Activating EGFR Mutation(INNOVATE)
Study Start Date : March 2014
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: chemotherapy and erlotinib
Intercalated combination of chemotherapy and erlotinib in 1st line setting for patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation
Drug: Intercalated combination of chemotherapy and erlotinib

Primary therapy stage:

Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.

Maintenance therapy stage:

Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.

Other Name: paclitaxel plus carboplatin and targeted therapy erlotinib




Primary Outcome Measures :
  1. Progression free survival defined by imagery methods [ Time Frame: 8 weeks ]
    From start of anti-cancer therapy untill progression or death


Secondary Outcome Measures :
  1. Toxicities related to anti-cancer therapy [ Time Frame: 8 weeks ]
    From start of anti-cancer therapy till progression of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.

Low abundant activating EGFR mutation: EGFR exon 19 deletion or exon 21 L858R, which are positive by real-time PCR methods and negative by standard sequencing methods.

Uncommon EGFR mutations are included excluding exon 20 mutations. ECOG performance status of ≤ 2. Patients can administer first line setting of platinum based chemotherapy. Patients must have measurable disease according to the RECIST (version 1.1) criteria.

  • Life expectancy of at least 12 weeks.
  • Age ≥ 18 years.
  • Written (signed) informed Consent to participate in the study.
  • Adequate organ function as defined by the following criteria:

Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.

Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin ≥90g/dl.

Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).

  • For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria:Patients with prior chemotherapy or systemic anti-cancer therapy including target therapy targeting HER family members (such as erlotinib, gefitinib, cetuximab, trastuzumab, etc). Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.

  • Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  • Patients who have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
  • Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
  • Nursing or lactating women.
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
  • Unwilling to write informed consent to participate in the study.
  • Patients who is unwilling to accept the follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095782


Locations
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China, Guangdong
Guangdong General Hospital & Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Investigators
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Study Chair: Yi-Long Wu Guangdong General Hospital (GGH)& Guangdong Academy of Medical Sciences
Principal Investigator: Zhen Wang, PhD Guangdong General Hospital & Guangdong Academy of Medical Sciences
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Responsible Party: Yi-Long Wu, Dr., Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT02095782    
Other Study ID Numbers: CTONG1307
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Keywords provided by Yi-Long Wu, Guangdong Association of Clinical Trials:
non-small cell lung cancer
erlotinib
chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors