A Trial for Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab Plus Pemetrexed Versus Pemetrexed Alone as Second Line Treatment of Stage IIIB or IV NSCLC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00735891
• Other study ID #: PSHCI 08-009
• Status: Terminated
• Phase: Phase 2
• First received: August 14, 2008
• Last updated: November 22, 2017
• Start date: December 2008
• Est. completion date: September 2016

Study information

• Verified date: November 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open-label, multicenter study for patients with advanced or metastatic non-small cell lung cancer (stage IIIB or IV). The objective of this study is progression-free survival of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIB or IV non-small cell lung cancer.

Description:

This phase II trial will address the issues of bevacizumab treatment duration and treatment safety by incorporating bevacizumab into a variation of the ECOG reference regimen as first-line therapy for patients with non-squamous non-small cell lung cancer. Following disease progression or treatment failure, the potential benefit of continued bevacizumab therapy will be tested by randomizing patients to two treatment arms, including second-line chemotherapy with or without further bevacizumab.

For first-line treatment, a regimen of carboplatin, docetaxel, and bevacizumab followed by maintenance bevacizumab therapy will be given to all patients. Upon disease progression or treatment failure, patients will be randomized to one of two second-line regimens: pemetrexed plus bevacizumab or pemetrexed monotherapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Histologically or cytologically confirmed stage IIIB with malignant pleural effusion or stage IV NSCLC except squamous-cell carcinoma.

• Measurable disease defined by RECIST.

• Adequate organ function

• Peripheral neuropathy = grade 1

• ECOG Performance Status 0-1

• Estimated survival of = 12 weeks

• Provide written informed consent

Exclusion Criteria:

• Prior chemotherapy for advanced NSCLC

• Neoadjuvant or adjuvant treatment within 6 months of registration

• Prior radiation therapy within 3 weeks of registration. All side effects must have resolved by registration

• Prior treatment with an investigational or marketed agent that acts by antiangiogenesis mechanisms

• Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels unless treated with palliative radiation

• Brain metastases or leptomeningeal disease, except for patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month prior to registration

• History of gross hemoptysis (defined as bright red blood of at least ½ teaspoon or 2.5 mL per episode) within 3 months of registration unless definitively treated with surgery, radiation, arteriographic embolization, or endobronchial interventions at least 4 weeks prior to registration

• Presence of cavitary lesion

• Presence of squamous histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable)

• Major surgery, open biopsy or significant traumatic injury within 4 weeks of registration or anticipation of need for major surgical procedure during the course of the study

• Minor surgical procedures, fine needle aspirations or core biopsies within

1 week prior to registration

• Current, ongoing therapeutic anticoagulation with full-dose warfarin or its equivalent

• Current or recent (within 10 days of the first dose of study treatment) use of aspirin (at least 325 mg/day) or other NSAIDs with anti-platelet activity or treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), or cilostazol (Pletal)

• History of prior malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or treated localized prostate cancer with a current PSA of < 1.0 mg/dL on two successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to registration

• History of serious systemic disease

• Pregnancy or women who are breast-feeding. Women of child-bearing potential and non-vasectomized men must agree to use effective methods of birth control during and 3 months following treatment period. Women of child- bearing potential must have a negative pregnancy test.

• History of severe hypersensitivity reaction to docetaxel or any other drugs formulated with polysorbate 80

• Any other medical condition, including mental illness or substance abuse, which in the judgment of the investigator, is likely to interfere with a patient's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results

• Use of any investigational agent within 4 weeks prior to registration

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• First-Line Treatment
Docetaxel 75 mg/m2, Carboplatin AUC=6,Bevacizumab 15 mg/kg administered in 21-day cycles on day 1 of each cycle.
• Maintenance
Bevacizumab 15 mg/kg maintenance in 21 day cycles for up to 18 cycles.
• Second-Line Treatment
Arm A: Pemetrexed 500 mg/m2 plus Bevacizumab 15 mg/kg administered in 21 day cycles on Day 1 of each cycle. Arm B: Pemetrexed 500 mg/m2 administered in 21 day cycles on Day 1 of each cycle.

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Patients will be followed up until their death for the overall survival time.	24 months
Secondary	Progression-free Survival Time.	participants are followed from randomization to disease progression	12 months