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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chandra P. Belani, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00735891
First received: August 14, 2008
Last updated: January 3, 2014
Last verified: January 2014

August 14, 2008
January 3, 2014
December 2008
July 2014   (final data collection date for primary outcome measure)
Progression-free survival of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV non-small cell lung cancer [ Time Frame: An expected average of 2 years ] [ Designated as safety issue: Yes ]
Progression-free survival of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV non-small cell lung cancer [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00735891 on ClinicalTrials.gov Archive Site
Survival [ Time Frame: An expected average of 2 years ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Trial for Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • 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.
    Other Name: Avastin
  • Drug: Maintenance
    Bevacizumab 15 mg/kg maintenance in 21 day cycles for up to 18 cycles.
    Other Name: Avastin
  • Drug: 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.
    Other Names:
    • Avastin
    • Alimta
  • Experimental: First Line Treatment
    All patients will receive first-line treatment in 21-day cycles for up to 6 cycles. All first-line medications are administered intravenously on Day 1 of each cycle. Response is assessed every 2 cycles until disease progression.
    Intervention: Drug: First-Line Treatment
  • Experimental: Maintenance
    Patients who have not progressed will continue on bevacizumab maintenance
    Intervention: Drug: Maintenance
  • Experimental: Second-Line Treatment
    Upon disease progression, eligible patients will be randomized for second-line treatment to one of two treatment arms. All second line medications are administered intravenously on Day 1 of each 21 day cycle until disease progression. Response is assessed every 2 cycles.
    Intervention: Drug: Second-Line Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2
July 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00735891
PSHCI 08-009
Yes
Chandra P. Belani, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: Chandra P Belani, MD Penn State College of Medicine
Milton S. Hershey Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP