Lung CancerPhase 2NCT00025389
Bevacizumab, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
A Phase 2 study testing bevacizumab, carboplatin and paclitaxel in people with Lung Cancer, run by University of Chicago at 2 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bevacizumab, carboplatin and paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2001to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Stage IB (T2, N0), II (T1 or T2, N1 or T3, N0), or IIIA (T3, N1)
- Potentially resectable disease
- No large central primary tumors in proximity to significant blood vessels
- No bronchoscopically evident endobronchial tumors
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1 OR
- Karnofsky 70-100%
Life expectancy:
- More than 12 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No history of an inherited bleeding disorder
- No inherited predisposition to a hypercoagulable state
- No clinically evident hypercoagulable state or bleeding diathesis
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
- INR less than 1.5
- PTT less than 36 seconds
Renal:
- Creatinine less than 1.5 times ULN OR
- Creatinine clearance at least 60 mL/min
- No nephrotic syndrome
- Urine protein no greater than 0.5 g/24 hours
Cardiovascular:
- No poorly controlled hypertension (greater than 150 mm Hg systolic and/or greater than 100 mm Hg diastolic) despite treatment
- No uncompensated coronary artery disease
- No myocardial infarction within the past 6 months
- No clinically significant or severe peripheral vascular disease
- No inherited predisposition to thrombosis
- No deep venous or arterial thrombosis
- No symptomatic congestive heart failure
- No unstable angina pectoris within the past 6 months
- No cardiac arrhythmia
- No transient ischemic attack within the past 6 months
- No cerebrovascular accident within the past 6 months
- No other arterial thromboembolic event within the past 6 months
Pulmonary:
- No hemoptysis
- No pulmonary embolism
Other:
- No history of allergic reactions to compounds of similar chemical or biologic composition to study drugs
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric illness or social situation that would preclude study compliance
- No significant traumatic injury within the past 28 days
- No uncontrolled concurrent illness
- No ongoing or active infection
- No serious, non-healing wound, ulcer, or bone fracture
- No other active malignancy
- No requirement for full-dose anticoagulation or thrombolytic therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy for this cancer
- No concurrent prophylactic growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF])
Chemotherapy:
- No prior chemotherapy for this cancer
- Prior chemotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled
Endocrine therapy:
- No prior endocrine therapy for this cancer
Radiotherapy:
- No prior radiotherapy for this cancer
- Prior radiotherapy for another malignancy allowed provided the prior malignancy was curatively treated and is currently controlled
- No concurrent radiotherapy
Surgery:
- Prior diagnostic bronchoscopy, mediastinoscopy, or CT-guided biopsy allowed
- At least 28 days since prior major surgical procedure or open biopsy
Other:
- No other concurrent investigational agents
- No other concurrent anticancer investigational or commercial agents or therapies
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent low-dose warfarin for maintenence of preexisting, permanent, indwelling IV catheters allowed provided INR less than 1.5
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210
About this study
Official title: A Phase 2 Study Of Neoadjuvant rhuMAb VEGF (Bevacizumab) In Combination With Paclitaxel And Carboplatin In Surgically Resectable Non-Small Cell Lung Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy before surgery may may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is to see if bevacizumab, paclitaxel, and carboplatin given before surgery work in treating patients who have stage IB, stage II, or stage IIIA non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the clinical complete and partial response rate in patients with stage IB, II, or IIIA resectable non-small cell lung cancer treated with neoadjuvant bevacizumab, paclitaxel, and carboplatin.
- Determine the pathologic complete response rate in patients treated with this regimen.
- Determine the ability to proceed with and complete a potentially curative resection in patients treated with this regimen.
- Determine the safety and toxicity of this regimen in these patients.
OUTLINE: Patients receive neoadjuvant bevacizumab IV over 60-90 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy.
Patients are followed within 3 months.
PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- bevacizumab, carboplatin, paclitaxel, conventional surgery, neoadjuvant therapy
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
carboplatinDrug
paclitaxelDrug
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Bevacizumab (15mg/kg, q3wk x 2), Paclitaxel (200 mg/m2, q3wk x 2), carboplatin (AUC of 6, q3wk x 2), followed by surgery 4 to 6 weeks after last dose of Bevacizumab Receives: Biological: bevacizumab; Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery; Procedure: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (complete and partial responses by RECIST)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2001
- Primary completionDec 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ann M. Mauer, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025389
- Sponsor's protocol ID
- 12653A
- Other IDs
- UCCRC-12653A, NCI-2655, OSU-0120
- Status last verified
- Feb 2013
- First submitted
- 11 Oct 2001
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Of Neoadjuvant rhuMAb VEGF (Bevacizumab) In Combination With Paclitaxel And Carboplatin In Surgically Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00025389
- Acronym / sponsor ID
- 12653A
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy before surgery may may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is to see if bevacizumab, paclitaxel, and carboplatin given before surgery work in treating patients who have stage IB, stage II, or stage IIIA non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the clinical complete and partial response rate in patients with stage IB, II, or IIIA resectable non-small cell lung cancer treated with neoadjuvant bevacizumab, paclitaxel, and carboplatin.
- Determine the pathologic complete response rate in patients treated with this regimen.
- Determine the ability to proceed with and complete a potentially curative resection in patients treated with this regimen.
- Determine the safety and toxicity of this regimen in these patients.
OUTLINE: Patients receive neoadjuvant bevacizumab IV over 60-90 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy.
Patients are followed within 3 months.
PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: bevacizumab, Drug: carboplatin, Drug: paclitaxel, Procedure: conventional surgery, Procedure: neoadjuvant therapyBevacizumab (15mg/kg, q3wk x 2), Paclitaxel (200 mg/m2, q3wk x 2), carboplatin (AUC of 6, q3wk x 2), followed by surgery 4 to 6 weeks after last dose of Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bevacizumab | Biological | Arm A |
| carboplatin | Drug | Arm A |
| paclitaxel | Drug | Arm A |
| conventional surgery | Procedure or surgery | Arm A |
| neoadjuvant therapy | Procedure or surgery | Arm A |
Primary outcome
Response Rate (complete and partial responses by RECIST)
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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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.
Ann M. Mauer, MD study chair
University of Chicago
2 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, carboplatin and paclitaxel in people with Lung Cancer, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response Rate (complete and partial responses by RECIST) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2013.