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

NCT ID: NCT01424709

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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.

Group Type: EXPERIMENTAL

Gemcitabine, Docetaxel, CPT-11,Cisplatin

Intervention Type: 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.

Arm 2

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

Group Type: ACTIVE_COMPARATOR

gemcitabine/cisplatin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

gemcitabine/cisplatin

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

Intervention Type: DRUG

Other Intervention Names

gemcitabine:Gemzar; Docetaxel:Taxotere; CPT-11:Irinotecan; gemcitabine:Gemzar

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Caicun Zhou

Tonji University Affiliated Shanghai Pulmonary Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caicun Zhou, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tongji University Affiliated Shanghai Pulmonary Hospital

Locations

Medical Department, Shanghai Pulmonary Hospital

Shanghai, , China

Countries

China

Other Identifiers

BRAVO study

Identifier Type: -

Identifier Source: org_study_id