Clinical trial · Interventional
Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
NCT00402883CI-TRIAL-00054965terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to bevacizumab and chemoradiotherapy toxicity
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| Folic Acid | Other | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Radiotherapy | Procedure | — | UNRESOLVED |
| vitamin B12 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Drug: Bevacizumab
- Drug: Pemetrexed
- Procedure: Radiotherapy
- Other: Folic Acid
- Other: vitamin B12
- Drug: carboplatin
Primary outcomes (1)
- measure
- Time to Progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTSpigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9. PMID 19901100