dMR During First Line Treatment of Non Squamous Lung Cancer: Time Course and Prognostic and Predictive Impact.

NCT02195336 | Unknown

• 2 other identifiers: BevMarML29273
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To date, there are no methods to reliably select which patients with non-squamous non-small cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome in some tumour types, including advanced NSCLC. Recent data are suggestive of a predictive value of imaging techniques for early detection of antiangiogenic treatment efficacy in different cancers. To our knowledge there are no presented data available on correlation between changes in diffusion-weighted MR and response to bevacizumab treatment in lung cancer. The current study is designed as a pilot study to prospectively investigate changes in MR variables during treatment with bevacizumab and to detect signals of prognostic and/or predictive value of MR changes during treatment.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• dMRT changes during treatment

  Diffusion magnetic resonance tomography of lung lesions.

  Baseline, Day 8, Day 28, Day 92, At relapse.

Secondary Outcomes (3)

• Response to treatment

  Baseline, Day 92, at 5, 7, 9, 12, 15, 18, 24 mo during follow up

• 3. Time to disease progression (defined as the time period from the start of first-line therapy to investigator assessed disease progression)

  Baseline, Day 92, at 5, 7, 9, 12, 15, 18, 24 mo during follow up

• Duration of survival

  At 5, 7, 9, 12, 15, 18, 24, 36 and 48 mo during follow up

Study Arms (1)

dMRT, Bevacizumab, Chemotherapy

EXPERIMENTAL

dMRT: Magnetic Resonance Tomograph, Baseline, day 8, day 28, day 92, progression/relapse. Bevacizumab: 7.5mg/kg every 3 weeks for 3 cycles. Standard of care NSCLC first-line chemotherapy, doublets containing paclitaxel and carboplatin are preferred, every 3 weeks for 3 cycles. Thereafter Bevacizumab 7.5mg/kg every 3 weeks until progression/relapse or unacceptable toxicity.

Device: dMRT; Drug: Bevacizumab; Drug: paclitaxel and carboplatin

Interventions

dMRT DEVICE

Baseline, day 8, day 28, day 92, progression/relapse.

Also known as: Magnetic Resonance Tomograph

dMRT, Bevacizumab, Chemotherapy

Bevacizumab DRUG

7.5mg/kg every 3 weeks for 3 cycles. Thereafter every 3 weeks until progression/relapse or unacceptable toxicity.

Also known as: Avastin

dMRT, Bevacizumab, Chemotherapy

paclitaxel and carboplatin DRUG

Standard of care NSCLC first-line chemotherapy Every 3 weeks for 3 cycles. Doublets containing paclitaxel and carboplatin are preferred

dMRT, Bevacizumab, Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to any study-specific procedure
• Age ≥18 years
• Able to comply with the protocol
• Histologically or cytologically documented inoperable, metastatic (Stage IV) non small cell lung cancer
• ECOG PS status 0-1
• Life expectancy ≥12 weeks
• Adequate haematological function:
• Normal values of absolute neutrophil and platelet count, and a hemoglobin value ≥9 g/dL
• Adequate liver function:
• Total bilirubin \<1.5 x ULN, AST, ALT \<2.5 x ULN
• Adequate renal function:
• Calculated creatinine clearance ≥50 mL/min, a urine dipstick for proteinuria \<2+.
• Normal values of INR within 7 days prior to enrolment
• If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to enrolment into the study.

You may not qualify if:

• Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
• Known EGFR mutation or ALK translocation
• History of haemoptysis
• Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava)
• Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases
• Previous treatment with chemotherapy or other anticancer agent
• Previous radiotherapy of the primary tumour. Palliative extrathoracic radiotherapy is allowed prior to enrolment or during treatment
• Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment
• Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
• Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (\> 325mg/day) or use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.
• History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
• Uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \>100 mmHg)
• Clinically significant (i.e. active) cardiovascular disease
• Non-healing wound, active peptic ulcer or bone fracture
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment

Sponsors & Collaborators

• Karl Kölbeck: lead

Study Sites (1)

Dept of Lung and Allergy, Karolinska university hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Karl-Gustav Kölbeck, MD

  Karolinska University Hospital, Dept of Lung and Allergy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl-Gustav Kölbeck, MD

CONTACT

+46-8-51774960; karl.kolbeck@karolinska.se

Eeva Alamartimo, RN

CONTACT

+46-8-51773918; eeva.alamartimo@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Consultant

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 21, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2018
• Last Updated: July 21, 2014

Record last verified: 2014-07

Locations

SE (1)