Non-small Cell Lung CancerPhase 2NCT00687817
Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing bavituximab plus paclitaxel and carboplatin in people with Non-small Cell Lung Cancer, run by Peregrine Pharmaceuticals at 9 sites in India.
Trial summary
The primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- bavituximab plus paclitaxel and carboplatin
- How many people
- 49 participants
- Where
- 9 sitesIndia
- Study dates
- Jun 2008to Jul 2010
- 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
Who may be able to join
- Adults over age 18 years of age with a life expectancy of at least 3 months
- Histologically or cytologically confirmed non-small cell lung cancer at stage IIIB (with pleural effusion), stage IV, or recurrence
- Measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral CT)
- Adequate hematologic (ANC ≥ 1500 cells/µL; Hemoglobin ≥9 g/dL; platelets ≥100,000/µL and ≤500,000/µL ), renal (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min), and hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN)
- D-dimer ≤ 2 x ULN
Who cannot join
- Small cell or mixed histology
- Known history of bleeding diathesis or coagulopathy
- Any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or GI bleeding
- Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
- Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
- Radiotherapy within 2 weeks preceding Study Day 1
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- Symptomatic or clinically active CNS disease or metastatic lesions
- Major surgery within 4 weeks of Study Day 1
- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
- Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
- A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. Anti-platelet agents are prohibited during the study.
- Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs, or steroids
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Apollo Hospital
Bannerghatta Rd, Banglore, 560 076
Kidwai Hospital
Munigowda Road, Banglore, 560 027
M S Ramaiah Hospital
New BEL Rd, Banglore, 560 054
Nizam's Institute of Medical Sciences
Panjagutta, Hyderabad, 500 082
Orchid Nursing Home
Phoolanbhaghan, Kolkata
Ruby Hall Clinic
Pune, Pune, 411-001
Bangalore Institute of Oncology Speciality Centre
Sampangi Ram Nagar, Banglore, 560 027
Yashoda Hospital
Somājigūda, Hyderabad, 500 082
RCC Medical College
Trivandrum, Kerala, 695 011
About this study
Official title: A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- bavituximab plus paclitaxel and carboplatin
- Keywords
- NSCLC
- 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.
bavituximab plus paclitaxel and carboplatinDrug
Weekly bavituximab dose of 3 mg/kg until disease progression, and up to 6 cycles of carboplatin at a dose of AUC=5 and paclitaxel 175 mg/m2 every 21 days (21-day cycles)
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer
Measured: one year
Secondary outcomes (1)
Time to tumor progression, duration of response, overall survival and safety
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687817
- Sponsor's protocol ID
- PPHM 0701
- Status last verified
- Mar 2011
- First submitted
- 28 May 2008
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Digumarti R, Bapsy PP, Suresh AV, Bhattacharyya GS, Dasappa L, Shan JS, Gerber DE. Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer. Lung Cancer. 2014 Nov;86(2):231-6. doi: 10.1016/j.lungcan.2014.08.010. Epub 2014 Aug 24.
PubMed 25236982
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00687817
- Acronym / sponsor ID
- PPHM 0701
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Jun 2008 (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.
The primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults over age 18 years of age with a life expectancy of at least 3 months
- Histologically or cytologically confirmed non-small cell lung cancer at stage IIIB (with pleural effusion), stage IV, or recurrence
- Measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral CT)
- Adequate hematologic (ANC ≥ 1500 cells/µL; Hemoglobin ≥9 g/dL; platelets ≥100,000/µL and ≤500,000/µL ), renal (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min), and hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN)
- D-dimer ≤ 2 x ULN
Key exclusion criteria (12 listed)
- Small cell or mixed histology
- Known history of bleeding diathesis or coagulopathy
- Any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or GI bleeding
- Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
- Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
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 |
|---|---|---|
| bavituximab plus paclitaxel and carboplatinWeekly bavituximab dose of 3 mg/kg until disease progression, and up to 6 cycles of carboplatin at a dose of AUC=5 and paclitaxel 175 mg/m2 every 21 days (21-day cycles) | Drug | – |
Primary outcome
Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer
Time frame: one year
1 secondary outcome
Time to tumor progression, duration of response, overall survival and safety
Time frame: Approximately 1 year
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 24 Mar 2011.
- Derived from this study: PubMed 25236982Digumarti R, Bapsy PP, Suresh AV, Bhattacharyya GS, Dasappa L, Shan JS, Gerber DE. Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer. Lung Cancer. 2014 Nov;86(2):231-6. doi: 10.1016/j.lungcan.2014.08.010. Epub 2014 Aug 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 bavituximab plus paclitaxel and carboplatin in people with Non-small Cell Lung Cancer, run by Peregrine Pharmaceuticals at 9 sites in India.
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 5 inclusion and 12 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 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. 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?
Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer (time frame: one year). 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 NCT00687817, which also lists 1 linked publication.
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 24 Mar 2011.