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

NCT00970684 | Completed Phase 2 Results DMC

• 4 other identifiers: CASE4507P30CA043703CASE 4507-CC694NCI-2010-00547
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival(PFS)

  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.

  1 year

Secondary Outcomes (2)

• Median Time to Progression

  1 year

• Best Response

  1 year

Study Arms (1)

Bevacizumab, Docetaxel, and Gemcitabine

EXPERIMENTAL

Treatment repeats every 21 days for up to 6 courses.

Biological: bevacizumab; Drug: docetaxel; Drug: gemcitabine hydrochloride

Interventions

bevacizumab BIOLOGICAL

15 mg/kg on day 1 of a 21-day cycle

Bevacizumab, Docetaxel, and Gemcitabine

docetaxel DRUG

75 mg/m2 on day 1

Bevacizumab, Docetaxel, and Gemcitabine

gemcitabine hydrochloride DRUG

900 mg/m2 on days 1, and 8,

Bevacizumab, Docetaxel, and Gemcitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed non-squamous cell non-small cell lung cancer * Stage IIIB (with pleural effusion), stage IV, or recurrent disease * Bidimensionally measurable disease * No known CNS disease, except for previously treated brain metastasis defined as no evidence of progression or hemorrhage after treatment AND no ongoing requirement for dexamethasone as documented by clinical examination, MRI, or CT scan * Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as deemed appropriate by the treating physician * Stable dose of anticonvulsants allowed * No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel, or large bowel) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 3 months * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Bilirubin ≤ 2.0 mg/dL * AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic metastases are present) * Serum creatinine ≤ 1.8 mg/dL * Urine protein:creatinine ratio \< 1.0 OR proteinuria \< 2+ by urine dipstick OR ≤ 1 g of protein by 24-hour urine collection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Available for regular follow-ups * No inadequately controlled hypertension, defined as systolic BP \> 150 mm Hg and/or diastolic BP \> 100 mm Hg despite antihypertensive medications * No history of hypertensive crisis or hypertensive encephalopathy * No NYHA class II-IV congestive heart failure * No myocardial infarction or unstable angina within the past 6 months * No stroke or transient ischemic attack within the past 6 months * No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring surgical repair, or recent peripheral arterial thrombosis) within the past 6 months * No symptomatic peripheral vascular disease * No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation) * No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis) * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No serious, nonhealing wound, ulcer, or bone fracture * No known hypersensitivity to any component of bevacizumab * No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months * No significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or biological therapy * No prior radiotherapy to an area of measurable disease unless there is documented progressive disease after completion of therapy * More than 2 weeks since prior radiotherapy * More than 4 weeks since prior and no concurrent participation in another experimental drug study, except for a Genentech-sponsored bevacizumab cancer study * More than 28 days since prior major surgical procedure or open biopsy * More than 3 months since prior abdominal surgery * More than 3 months since prior neurosurgical resection or brain biopsy * More than 7 days since prior core biopsy or other minor surgical procedure, except placement of a vascular access device * No concurrent major surgical procedure

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nathan Pennell, MD, PhD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Fairview Hospital, Moll Pavilion

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Hillcrest Hospital, a Cleveland Clinic Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Related Publications (1)

• Patil PD, Shapiro M, Hashemi Sadraei N, Pennell NA. An Open-Label Phase II Trial of Bevacizumab plus Docetaxel and Gemcitabine in Advanced, Previously Untreated Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2019 Apr;24(4):457-e126. doi: 10.1634/theoncologist.2018-0857. Epub 2019 Jan 2.

  PMID: 30602615 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Bevacizumab; Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Nathan Pennell MD
• Organization: Case Comprehensive Cancer Center

penneln@ccf.org

216-445-9285

Study Officials

• Nathan Pennell, MD, PhD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Afshin Dowlati, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 16, 2022
• Results First Posted: February 4, 2014

Record last verified: 2022-07

Locations

US (4)