Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Biological: bevacizumab; Drug: docetaxel; Drug: gemcitabine hydrochloride

• Registration Number: NCT00970684
• Lead Sponsor: Nathan Pennell, MD, PhD

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

* Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, docetaxel, and gemcitabine hydrochloride.

Secondary

* Evaluate the median time to progression in patients treated with this regimen.

* Estimate the response rate in patients treated with this regimen.

* Determine the median overall survival of patients treated with this regimen.

* Determine the incidence of adverse events associated with this regimen in these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease may then continue to receive bevacizumab alone for up to 12 months in the absence of disease progression.

After completion of study treatment, patients are followed up every 3 months.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2013-12-18
• Results First Submitted QC: 2013-12-18
• Results First Posted: 2014-02-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab, Docetaxel, and Gemcitabine	bevacizumab	Treatment repeats every 21 days for up to 6 courses.
Bevacizumab, Docetaxel, and Gemcitabine	gemcitabine hydrochloride	Treatment repeats every 21 days for up to 6 courses.
Bevacizumab, Docetaxel, and Gemcitabine	docetaxel	Treatment repeats every 21 days for up to 6 courses.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival(PFS)	1 year	PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.

Secondary Outcome Measures

Name	Time	Method
Best Response	1 year	The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)
Median Time to Progression	1 year	Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.

Trial Locations

Locations (4)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Fairview Hospital, Moll Pavilion; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Hillcrest Hospital, a Cleveland Clinic Hospital; 🇺🇸 Mayfield Heights, Ohio, United States