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

Non-small Cell Lung Cancer Clinical Trial

— BRAVO  

Official title:

Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01424709
• Other study ID #: BRAVO study
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 9, 2011
• Last updated: September 23, 2014
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Tongji University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Gemcitabine, Docetaxel, CPT-11,Cisplatin
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.
• gemcitabine/cisplatin
gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity.

Locations

Country	Name	City	State
China	Medical Department, Shanghai Pulmonary Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	to evaluate ORR during 6-8 weeks after all cycles complete	tumor assessment 6-8 weeks after the initiation of chemotherapy	No
Secondary	Progression free survival	PFS is evaluated in the 24th month since the treatment began	24 months	Yes
Secondary	duration of response	evaluated in the 24th month since the treatment began	24 months	Yes
Secondary	overall survival	evaluated in the 24th month since the treatment began	24 months	Yes
Secondary	safety	evaluated in the 24th month since the treatment began	24 months	Yes
Secondary	Quality Of Life	evaluated in the 24th month since the treatment began	24 months	Yes