Non-small Cell Lung CancerPhase 2NCT00661778

A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Bevacizumab, Cisplatin and Docetaxel in people with Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 14 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: Bevacizumab, Cisplatin and Docetaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 14 sitesSpain
Study dates: Jul 2007to Jul 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients, ≥ 18 years of age.
Stage IIIb or IV non-small cell lung cancer.
Chemotherapy-naive.

Who cannot join

Previous treatment for non-small cell lung cancer.
Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study.
Recent or current chronic treatment with aspirin (> 325 mg/day).

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Spain14 sites

Study site
Alcalá de Henares, Madrid, 28805
Study site
Cadiz, Cadiz, 11009
Study site
Castellon, Castellon, 12002
Study site
Donostia / San Sebastian, Guipuzcoa, 20080
Study site
Madrid, Madrid, 28036
Study site
Madrid, Madrid, 28935
Study site
Málaga, Malaga, 29010
Study site
Palencia, Palencia, 34005
Study site
Palma de Mallorca, Balearic Islands, 07198
Study site
Sagunto, Valencia, 46520
Study site
Valencia, Valencia, 46017
Study site
Valladolid, Valladolid, 47005
Study site
Valladolid, Valladolid, 47010
Study site
Zamora, Zamora, 49021

Other trials in Spain

About this study

Official title: An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.

Conditions: Non-small Cell Lung Cancer
Being tested: Bevacizumab, Cisplatin, Docetaxel
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BevacizumabDrug
Also called Avastin
Bevacizumab was supplied as a sterile liquid in glass vials.
CisplatinDrug
Bevacizumab was supplied as a sterile liquid in glass vials.
DocetaxelDrug
Also called Taxotere
Bevacizumab was supplied as a sterile liquid in glass vials.

Study groups in NCT00661778
Study group	Role	What they receive
Bevacizumab + cisplatin + docetaxel	Experimental	Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent. Receives: Drug: Bevacizumab; Drug: Cisplatin; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Measured: Baseline to the end of the study (up to 4 years)

Secondary outcomes (4)

Percentage of Participants With an Objective Response
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Measured: Baseline to the end of the study (up to 4 years)
Duration of the Objective Response
Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Measured: Baseline to the end of the study (up to 4 years)
Overall Survival
Overall survival is defined as the time from the first dose of study medication until death.
Measured: Baseline to the end of the study (up to 4 years)
1-year Survival
The probability of surviving 1 year was estimated using the Kaplan-Meier method.
Measured: Baseline to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Jul 2011

First posted18 Apr 2008 (estimated)
Study startJul 2007
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00661778
Sponsor's protocol ID: ML20081
Other IDs: 2006-005619-88
Status last verified: Jul 2014
First submitted: 17 Apr 2008
Last updated: 10 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00661778
Acronym / sponsor ID: ML20081
Conditions: Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 18 Apr 2008 (estimated)
Results: Posted 10 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bevacizumab + cisplatin + docetaxel	Experimental	Drug: Bevacizumab, Drug: Cisplatin, Drug: DocetaxelParticipants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult patients, ≥ 18 years of age.
Stage IIIb or IV non-small cell lung cancer.
Chemotherapy-naive.

Key exclusion criteria (4 listed)

Previous treatment for non-small cell lung cancer.
Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study.
Recent or current chronic treatment with aspirin (> 325 mg/day).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BevacizumabAlso: AvastinBevacizumab was supplied as a sterile liquid in glass vials.	Drug	Bevacizumab + cisplatin + docetaxel
CisplatinBevacizumab was supplied as a sterile liquid in glass vials.	Drug	Bevacizumab + cisplatin + docetaxel
DocetaxelAlso: TaxotereBevacizumab was supplied as a sterile liquid in glass vials.	Drug	Bevacizumab + cisplatin + docetaxel

Primary outcome

Progression-free Survival
Time frame: Baseline to the end of the study (up to 4 years)
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.

4 secondary outcomes

Percentage of Participants With an Objective Response
Time frame: Baseline to the end of the study (up to 4 years)
Duration of the Objective Response
Time frame: Baseline to the end of the study (up to 4 years)
Overall Survival
Time frame: Baseline to the end of the study (up to 4 years)
1-year Survival
Time frame: Baseline to 1 year

Results and safety

Results posted to the registry on 10 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bevacizumab + Cisplatin + Docetaxel	50	0

Primary outcome: Progression-free Survival

Time frame: Baseline to the end of the study (up to 4 years). Median (95% Confidence Interval). Unit: Months

Measure	Bevacizumab + Cisplatin + Docetaxel n = 49
Value	8.95 (6.92 to 9.97)

Population analysed: Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bevacizumab + Cisplatin + Docetaxel	26 of 49 (53.1%)	48 of 49 (98%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Non-small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Cisplatin and Docetaxel in people with Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 14 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: Baseline to the end of the study (up to 4 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00661778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.