Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC

NCT00647426 | Completed Phase 2 Results

• 1 other identifier: UPCC 12506
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single institution, phase II study of Sorafenib in combination with docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib twice a day on the 1st day of treatment and continue to take the medication every day until progression of disease, prohibitive toxicity, or patient withdrawal from the study. Chemotherapy courses will repeat every 21 days in the absence of disease progression or unacceptable toxicity for a total of four cycles.

Conditions

Non-Small Cell Lung Cancer

Keywords

Stage IIIB/IV

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin

  The response rate from the combination therapy of Sorafenib and Docetaxel/carboplatin for patients with Stage IIIB/IV NSCLC.The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria (see section 9.3.1).Tumor Response: Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): a) At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): a) At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  30 months

Secondary Outcomes (3)

• Number of Participants the Progression-free Survival (PFS) .

  30 months

• Number of Participants With Serious Adverse Events

  30 months

• The Number of Participants With Biomarkers of Sorafenib Activity and Toxicity

  30 months

Study Arms (1)

Sorafenib + Docetaxel/Carboplatin

EXPERIMENTAL

400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle

Drug: Sorafenib + Docetaxel/Carboplatin

Interventions

Sorafenib + Docetaxel/Carboplatin DRUG

400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle

Also known as: Carboplatin: Paraplatin, CBDCA

Sorafenib + Docetaxel/Carboplatin

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed NSCLC with clinical or radiological evidence of advanced disease (Stage IIIB/IV)
• Uni-dimensionally measurable disease
• Age =\> 18 years
• ECOG performance status of 0-1
• Life expectancy \> 3 months

You may not qualify if:

• Small-cell or mixed histologies including a small cell component
• Prior chemotherapy, biotherapy, radiotherapy to an area of measurable disease
• Patients with peripheral neuropathy grade =\> 2

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Sorafenib; Docetaxel; Carboplatin

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Tracey Evans MD
• Organization: Abramson Cancer Center

Christine.Bonney@UPHS.upenn.edu

215 614 0861

Study Officials

• Tracey Evans, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 31, 2008
• Study Start: November 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2012
• Last Updated: October 22, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-09

Locations

US (1)