Individualized Chemotherapy Based on BRCA1 and RRM1 mRNA for Advanced Non-small Cell Lung Cancer (NSCLC)

NCT01424709 | Unknown Phase 2 DMC

• 1 other identifier: BRAVO study
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Gemcitabine, docetaxel, CPT-11 and cisplatin are effective in 1st line treatment of advanced non-small cell lung cancer (NSCLC). Platinum-based doublets including gemcitabine, docetaxel or CPT-11 are standard 1st regimens. BRCA1 and RRM1 expression levels are reported to be associated with sensitivity of the tumor cells to cytotoxic agents. Some Phase II or III trials did prove feasibility of customized chemotherapy based upon expression levels of one or two biomarkers in the NSCLC patients. The investigators think customized chemotherapy may further improve efficacy of chemotherapy in advanced NSCLC. But there is no randomised trial to compare efficacy of standard chemotherapy with individualized chemotherapy in this setting. So, the investigators plan to initiate this phase II trial to compare efficacy between standard chemotherapy of gemcitabine/cisplatin versus customized chemotherapy in chemonaive NSCLC patients.

Conditions

Non-small Cell Lung Cancer

Keywords

Chemotherapy; Individual therapy; RRM1; BRCA1

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  to evaluate ORR during 6-8 weeks after all cycles complete

  tumor assessment 6-8 weeks after the initiation of chemotherapy

Secondary Outcomes (5)

• Progression free survival

  24 months

• duration of response

  24 months

• overall survival

  24 months

• safety

  24 months

• Quality Of Life

  24 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Based on expression levels of RRM1 and BRCA1 mRNA，one of the four regimens will be given to each patient: Gemcitabine/cisplatin, Docetaxel/gemcitabine, CPT-11/Cisplatin, docetaxel monotherapy. The chemotherapy will be repeated every 3 week. Dose reduction or interruption for toxicity could take place at any time.

Drug: Gemcitabine, Docetaxel, CPT-11,Cisplatin

Arm 2

ACTIVE COMPARATOR

gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity.

Drug: gemcitabine/cisplatin

Interventions

Gemcitabine, Docetaxel, CPT-11,Cisplatin DRUG

Based on expression levels of RRM1 and BRCA1 mRNA，one of the four regimens will be given to each patient: Gemcitabine/cisplatin, Docetaxel/gemcitabine, CPT-11/Cisplatin, docetaxel monotherapy. The chemotherapy will be repeated every 3 week. Dose reduction or interruption for toxicity could take place at any time.

Also known as: gemcitabine:Gemzar, Docetaxel:Taxotere, CPT-11:Irinotecan

Arm 1

gemcitabine/cisplatin DRUG

gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity.

Also known as: gemcitabine:Gemzar

Arm 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent,
• Histologically confirmed stage M1a or M1b NSCLC,
• Aged over 18 years old,
• Measurable disease,
• Life expectancy of at least 12 weeks,
• No prior chemotherapy or target therapy,
• No brain metastases or spinal cord compression,
• Less than 10% body weight loss,
• ECOG performance status 0-2,
• Adequate vital organ function (haematological, renal, hepatic, etc).
• Enough tissue for detection of BRCA1 and RRM1 expression.

You may not qualify if:

• Prior systemic cytotoxic chemotherapy or EGFR TKI therapy,
• Positive pregnancy test,
• Another active malignancy, other than superficial basal cell and squamous cell or carcinoma in situ of the cervix, within the last 5 years,
• Patients with brain metastases or spinal cord compression,
• Allergy to gemcitabine, cisplatin, docetaxel, CPT-11,
• Any unstable systemic disease including active infection,
• No enough tissue for detection of BRCA1 and RRM1

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Medical Department, Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Caicun Zhou, Ph.D

  Tongji University Affiliated Shanghai Pulmonary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tonji University Affiliated Shanghai Pulmonary Hospital

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: August 29, 2011
• Study Start: December 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

CN (1)