Pemetrexed Plus Bevacizumab in Pretreated, Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 2
- Intervention
- Pemetrexed
- Conditions
- Non-small-cell Lung Cancer
- Sponsor
- Hellenic Oncology Research Group
- Enrollment
- 50
- Locations
- 10
- Primary Endpoint
- Progression Free Survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial will evaluate the efficacy and safety of pemetrexed and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer (NSCLC).
Detailed Description
Pemetrexed is and an effective and well tolerated cytotoxic agent in the 2nd line treatment of advanced or metastatic non small cell lung cancer (NSCLC). Recently, a phase III study of 1st line treatment in patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. There are patients with NSCLC who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. The evaluation of bevacizumab plus chemotherapy in such patients is justified. This study will evaluate the combination of pemetrexed and bevacizumab as 2nd or 3rd line treatment of NSCLC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed,
- •Unresectable locally advanced (stage IIIB) or metastatic (stage IV) non-squamous NSCLC
- •At least one and no more than two previous chemotherapy regimens for advanced - or metastatic NSCLC
- •Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm.
- •Age ≥ 18 years.
- •Performance status (WHO) 0-
- •Life expectancy of at least 12 weeks.
- •Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 Upper normal limit, SGOT/SGPT ≤ 2.5 Upper normal limit in the absence of liver metastases or ≤ 5 Upper normal limit in the presence of liver metastases), and renal function (Creatinine ≤ 1,5 Upper normal limit).
- •Patients must be able to understand the nature of this study and give written informed consent
Exclusion Criteria
- •Previous therapy with pemetrexed
- •Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- •Pregnant or lactating women
- •Any serious, uncontrolled comorbidity on the investigator's judgment. Uncontrolled infection
- •Any sustained chronic toxicity \> grade 2 according to the NCI CTCAE (version 3.0)
- •Symptomatic neuropathy \> grade 2 according to the NCI CTCAE (version 3.0)
- •Brain metastases, except if radiated and asymptomatic
- •Radiotherapy within the previous 4 weeks
- •Previous radiotherapy to the only measurable lesion
- •Proteinuria ≥ 500 mgr of protein daily
Arms & Interventions
1
Pemetrexed/Bevacizumab
Intervention: Pemetrexed
1
Pemetrexed/Bevacizumab
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 1 year
Secondary Outcomes
- Overall Survival(1 year)
- Overall response rate(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Quality of life assessment(Assessment every two cycles)
- Toxicity profile(Assessment every two cycles)