Clinical trial NCT01424709: Individualized Chemotherapy Based on BRCA1 and RRM1 mRNA for Advanced Non-small Cell Lung Cancer (NSCLC)
Official title: Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Chemotherapy
Individual therapy
RRM1
BRCA1
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Primary end point:ORR Secondary end point:PFS,OS,safety,QOL,etc.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall response rate
timeFrame: tumor assessment 6-8 weeks after the initiation of chemotherapy
Secondary outcomes:
measure: Progression free survival
timeFrame: 24 months
measure: duration of response
timeFrame: 24 months
measure: overall survival
timeFrame: 24 months
measure: safety
timeFrame: 24 months
measure: Quality Of Life
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Medical Department, Shanghai Pulmonary Hospital
Study officials:
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
name: Caicun Zhou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: