Open label study of bevacizumab maintenance therapy (AVASTIN?) with or without pemetrexed after a first line treatment chemotherapy with bevacizumab-cisplatin-pemetrexed in patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) - AVAPERL-1

Phase 1

• Conditions: ocally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic or recurrent non squamous non-small cell lung cancer (NSCLC); MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB

• Registration Number: EUCTR2008-007008-27-NL
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-18
• Study Completion: 2011-05-03
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

- Age = 18 years.
- Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-squamous NSCLC.
- At least 1 unidimensionally measurable lesion meeting RECIST criteria (at least 10 mm in longest diameter [LD] by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques). Positron emission tomography (PET) scans and ultrasounds may not be used for tumor measurements.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- Life expectancy =16 weeks.
- Adequate hematological function:
Absolute neutrophil count (ANC) = 1.5 x 109/L AND
Platelet count = 100 x 109/L AND
Hemoglobin = 9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function:
Total bilirubin < 1.5 x upper limit of normal (ULN) AND
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 2.5 x ULN in patients without liver metastases; < 5 x ULN in patients with liver metastases.
- Adequate renal function:
Calculated creatinine clearance according to the formula of Cockroft and Gault = 50 mL/min AND
Urine dipstick for proteinuria < 2+. Patients discovered to have = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate = 1 g of protein in 24 hours.
- International normalized ratio (INR) = 1.5 and activated prothrombin time (aPPT) = 1.5 x ULN within 7 days prior to enrolment.
- Female patients should not be pregnant or breast-feeding. Female patients with childbearing potential should agree to use effective, non hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of at least 6 months following the last administration of study drugs. Female patients with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 7 days days prior to enrolment into the study.
- Fertile male patients must agree to use effective contraception during the study and for a period of at least 6 months following the last administration of study drugs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with predominant squamous component.
2.Prior chemotherapy or treatment with other systemic anti-cancer agent for lung cancer (including monoclonal antibodies or tyrosine kinase inhibitors), except for adjuvant chemotherapy if completed more than 3 years before enrolment.
3.Malignancies other than NSCLC within 5 years before randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent.
4.History of haemoptysis = grade 2 (bright red blood of at least 2.5 mL within prior 3 months).
5.Evidence of tumor invading major blood vessels.
6.Radiotherapy within prior 28 days.
7.Surgery (including open biopsy), significant traumatic injury within prior 28 days or anticipatied need for major surgery during study treatment.
8.Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to first bevacizumab dose.
9.Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (> 325 mg/day), or full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
10.Patient unable or unwilling to take folic acid, vitamin B12 or corticosteroids.
11.Clinically detectable third-space fluid collections, e.g. ascites or pleural effusions that cannot be controlled prior to study entry.
12.History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
13.Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg).
14.Clinically significant (i.e. active) cardiovascular disease, e.g., CVA (= 6 months before enrolment), MI (= 6 months before enrolment), unstable angina, CHF NYHA Class = II, serious cardiac arrhythmia requiring medication that might interfere with administration of the study treatment, or not controlled by medication.
15.Non-healing wound, active peptic ulcer or bone fracture.
16.History of abdominal fistula, GI perforation or intra abdominal abscess within 6 months of enrolment.
17.Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
18.Known hypersensitivity to bevacizumab, any of its excipients, or any of the study drugs.
19.Evidence of other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified