Clinical trial NCT00378573: Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official title: A Phase II, Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-09-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS) after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured from the date of registration (ie, assignment of subject number when subject meets all entry criteria) to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurs first.


Eligibility criteria: The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Inclusion Criteria:

1. Histologic or cytologic confirmation of locally advanced (pleural effusion) or metastatic (Stage IIIB/IV) NSCLC (non-squamous-cell histology only), mixed tumor types can be selected based on predominant cell type unless small cell elements are discovered (in which case the subject is not eligible);
2. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional computerized tomography (CT) or magnetic resonance imaging (MRI) scans, or as \>/= 10 mm with spiral computerized tomography (CT) scan
3. No previous systemic chemotherapy
4. Estimated life expectancy of \>/= 12 weeks
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
6. Nonpregnant, nonlactating female subjects; male and female subjects of childbearing potential must be willing to use an effective form of contraception while on therapy and for 90 days thereafter; an effective form of contraception is defined as an oral contraceptive or a double barrier method; pregnancy is to be determined/ ruled out through the use of serum human chorionic gonadotropin (HCG)
7. Subjects must have adequate renal function as determined by the following within 1 week prior to study registration: Calculated creatinine clearance \>45 mL/min using Cockcroft-Gault formula; Urine protein: creatinine (UPC) ratio \<1.0 by spot urinalysis; Urine dipstick for protein \<2+ (subjects discovered to have \>= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \</= 1 g of protein in 24 hours to be eligible);
8. Hematologic evaluation within 2 weeks prior to study registration (minimum values): Absolute neutrophil count (ANC) \>/= 1500 mm3; Platelet count \>/= 100,000 mm3; Hemoglobin (Hg) \>/= 9.9 g/dL (erythropoietin may be transfused to maintain or exceed this level); Partial thromboplastin time (PTT) no greater than upper limit of normal (ULN)
9. Hepatic function evaluation within 2 weeks prior to study registration (as detailed in protocol provided to Investigator): Total bilirubin \</= upper limit of normal; Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase must be within the range allowing for eligibility; In determining eligibility the more abnormal of the two values (AST or ALT) should be used (details for decision in full protocol as provided to Investigator)

Exclusion Criteria:

1. Receipt of prior systemic chemotherapy, vascular endothelial growth factor (VEGF) or endothelial growth factor receptor (EGFR) inhibitor therapy at any time; receipt of recent or current radiation therapy; current, recent (within 4 weeks prior to study registration), or planned receipt of investigational therapy (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
2. Subjects with cardiovascular diseases and related treatments
3. Surgical procedure in anamnesis (medical history): Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, or anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures (eg, fine needle aspirations, core biopsies) within 7 days prior to registration;
4. Serious non-healing wound, ulcer, or bone fracture;
5. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration;
6. History of gross hemoptysis (defined as bright red blood of \>/= 0.5 teaspoon)
7. History of hypersensitivity reaction to drugs formulated with polysorbate 80;
8. Subjects with brain metastases;
9. Peripheral neuropathy \>/= Grade 2 (based on Common Toxicity Criteria Adverse Event \[CTCAE\] v3.0);
10. History of a malignancy other than NSCLC; exceptions to this include: Curatively treated basal cell carcinoma; cervical intraepithelial neoplasia; or localized prostate cancer with a current prostate-specific antigen (PSA) of \<1.0 ng/dL on 2 successive evaluations at least 3 months apart, and the most recent evaluation within 4 weeks of study registration; History of another malignancy that was curatively treated and no evidence of disease for a minimum of 5 years;
11. Symptoms of a clinically meaningful illness in the 90 days before the study, or history of other disease, (such as human immunodeficiency virus (HIV) positive, chronic infection (eg, pulmonary tuberculosis), or hepatitis A, B or C (active or previously treated), active infection with fever, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that might affect the interpretation of the results of the study, or render the subject at high risk from treatment complications; (testing for these conditions will be at investigator discretion)
12. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

Primary outcomes:
measure: Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy
timeFrame: 1 year post-registration
Secondary outcomes:
measure: Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 1 year from start of treatment
measure: Overall Survival
timeFrame: 2 years post-registration
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Phyllis Diener, BS, MT (ASCP)
role: STUDY_DIRECTOR
References: