Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

This study has been terminated.
(Terminated due to bevacizumab and chemoradiotherapy toxicity)
Sponsor:
Collaborators:
Genentech
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00402883
First received: November 21, 2006
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: Bevacizumab
Drug: Pemetrexed
Procedure: Radiotherapy
Other: Folic Acid
Other: vitamin B12
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Evaluate the Objective Response Rates [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: November 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
Drug: Bevacizumab
15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
Other Name: Avastin
Drug: Pemetrexed
500mg/m2 week 1, 4, 16, 19 and 22.
Other Name: Alimta
Procedure: Radiotherapy
1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
Other Name: RT
Other: Folic Acid
350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.
Other: vitamin B12
1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.
Drug: carboplatin
AUC=5 administered intravenously weeks 1 and 4.

Detailed Description:

The patients on this study will receive treatment in 3 stages of therapy.

The first stage is Induction Therapy. This therapy is 7 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 1 and 4. During Induction patients will also receive radiation therapy daily, Monday through Friday, for 7 weeks (weeks 1-7). This is followed by 2 weeks of rest. During this rest period patients will have scans done to see how their disease has responded to treatment.

The next stage of treatment is Consolidation Therapy. This stage is 10 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 10, 13 and 16. This is followed by 3 weeks rest. During week 19 patients will have scans to see how their disease has responded to treatment.

The last stage of treatment is Maintenance Therapy. Patients will receive bevacizumab alone by vein every 3 weeks. Treatment will be given every three weeks for up to 9 treatments. (week 45)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically confirmed non-small cell lung cancer stage IIIA and selected stage IIIB
  • Measurable or evaluable disease
  • Be up and about and able to care for self
  • Adequate kidney, liver and bone marrow function
  • No prior treatment for this disease
  • Must be able to give written informed consent
  • Must be able to take folic acid, vitamin B12 and dexamethasone as described in the protocol
  • Age 18 years or older

Exclusion Criteria:

  • Stage IV or IIIB patients with pleural or pericardial effusions
  • Stage IIIB disease with contralateral mediastinal nodes greater than 4cm
  • Squamous cell predominant tumors
  • Pregnant or lactating women
  • Patients with active infections
  • History of another cancer within the last 5 years with the exception of skin cancer or cervical carcinoma in situ
  • History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
  • Symptoms of peripheral vascular disease
  • History of neurological disease
  • Recent history of blood in the sputum or vomitus
  • Non-healing wounds, ulcer or long bone fractures
  • History of bleeding problems or coagulation problems
  • History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months
  • History of uncontrolled hypertension
  • Chronic use of non-steroidal anti-inflammatory medication not allowed on this study

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402883

Locations
United States, Florida
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States, 32605
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805
United States, Georgia
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Associates in Hematology Oncology
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech
Eli Lilly and Company
Investigators
Principal Investigator: David Spigel, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00402883     History of Changes
Other Study ID Numbers: SCRI LUN 134
Study First Received: November 21, 2006
Results First Received: August 15, 2013
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Folic Acid
Hydroxocobalamin
Vitamin B Complex
Vitamin B 12
Bevacizumab
Vitamins
Pemetrexed
Carboplatin
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014