Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00402883 |
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Recruitment Status :
Terminated
(Terminated due to bevacizumab and chemoradiotherapy toxicity)
First Posted : November 22, 2006
Results First Posted : January 13, 2014
Last Update Posted : November 9, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer | Drug: Bevacizumab Drug: Pemetrexed Procedure: Radiotherapy Other: Folic Acid Other: vitamin B12 Drug: carboplatin | Phase 2 |
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)
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | November 2006 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | January 2009 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
- Time to Progression [ Time Frame: 18 months ]
- Objective Response Rate [ Time Frame: 18 months ]The objective benefit is defined as substantial shrinkage in tumor volume per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and is assessed by MRI or CT. Objective response = complete response + partial response. Complete Response (CR) is defined as the Disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions.
- Overall Survival [ Time Frame: 18 months ]Overall survival was defined as the interval between the date of study entry until the date of death
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402883
| 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 | |
| Principal Investigator: | David Spigel, MD | SCRI Development Innovations, LLC |
Publications of Results:
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00402883 |
| Other Study ID Numbers: |
SCRI LUN 134 |
| First Posted: | November 22, 2006 Key Record Dates |
| Results First Posted: | January 13, 2014 |
| Last Update Posted: | November 9, 2021 |
| Last Verified: | November 2021 |
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Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Folic Acid Vitamin B 12 Hydroxocobalamin Bevacizumab Carboplatin Pemetrexed Antineoplastic Agents, Immunological |
Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Vitamins Micronutrients Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Hematinics Vitamin B Complex |