Clinical trial · Interventional
Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC
Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer
NCT00519831CI-TRIAL-00028060terminatedPhase 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): Drug unavailable
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving vinflunine together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vinflunine together with cetuximab works as second-line therapy in treating patients with stage IIIB or stage IV 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| vinflunine | Drug | Vinflunine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vinflunine + Cetuximab
- description
- Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
- interventionNames
- Biological: cetuximab
- Drug: vinflunine
Primary outcomes (1)
- measure
- Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).
- timeFrame
- Baseline, after cycle 2, within 2 weeks of completing cycle 4
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
* Unresectable stage IIIB disease with pleural effusion or pericardial effusion
* Stage IIIB disease that was treated with chemotherapy alone as first-line therapy
* Stage IV disease
* Must have documented progression of disease after receiving one cytotoxic chemotherapy regimen for metastatic disease
* At least one lesion that is bidimensionally measurable by CT scan or MRI
* Must have evaluable disease outside the radiation field
* New lesions that develop within the radiation field are allowed
* Measurable disease status as defined by RECIST criteria
* Brain metastases allowed provided they have been previously treated and are controlled
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Absolute neutrophil count (ANC) \> 1,000/mm³
* Hemoglobin \> 8.0 g/dL
* Platelet count \> 75,000/mm³
* Creatinine \< 2.0 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 times ULN
* Total bilirubin \< 2.5 times ULN
* Prior malignancy allowed provided the patient's life expectancy is best defined by the diagnosis of NSCLC
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 4 weeks after completion of study therapy
Exclusion criteria:
* Peripheral neuropathy ≥ 2
* Severe allergic reaction to prior vinca alkaloid treatment
* Active or uncontrolled infection
* Significant history of uncontrolled cardiac disease, including any of the following:
* Uncontrolled hypertension
* Unstable angina
* Myocardial infarction within the past 6 months
* Uncontrolled congestive heart failure
* Cardiomyopathy with decreased ejection fraction
* Severe reaction to prior monoclonal antibody therapy
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* See Disease Characteristics
* Prior oral tyrosine kinase inhibitor therapy (e.g. gefitinib or erlotinib) allowed
* Not considered cytotoxic therapy for study eligibility purposes if given alone as first-line therapy
* At least 1 week since prior radiotherapy
* At least 21 days since prior and no other concurrent chemotherapy
* Prior adjuvant therapy allowed provided patient received one cytotoxic chemotherapy regimen as treatment for metastatic disease
* Prior bevacizumab allowed
Exclusion criteria:
* Two or more cytotoxic chemotherapy regimens as treatment for metastatic disease
* Prior therapy with monoclonal antibody directed at the epidermal growth factor receptor (EGFR) pathway
* Prior therapy with a vinca alkaloid in the metastatic setting
* Concurrent bevacizumab
* Other concurrent investigational agent(s)
* Concurrent colony-stimulating factors as primary prophylaxis for the prevention of febrile neutropenia
* Concurrent CYP3A4 inhibitor(s)References
Publications (0)
Data not yet available
No reference posted for this study.