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Small Cell Lung CancerPhase 2NCT00317200

A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer

A Phase 2 study testing Paclitaxel and Bevacizumab in people with Small Cell Lung Cancer, run by Hoosier Cancer Research Network at 17 sites in United States.

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

Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC, including in refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are associated with worse outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Paclitaxel and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
17 sitesUnited States
Study dates
Apr 2006to Nov 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

Who may be able to join

  • Histologic or cytologic proof of small cell lung cancer
  • Chemo-sensitive disease defined as relapsed after 60 days from completion of first line chemotherapy.
  • Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy.
  • Must have received treatment with at least 1 but not more than 2 prior chemotherapy regimens. (At least one regimen must contain a platinum agent. Previous treatment with irinotecan is allowed.)
  • Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade 1 or baseline prior to registration.
  • Prior cancer treatment must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen prior to registration.

Who cannot join

  • No treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
  • No history or radiographic evidence of CNS involvement by head CT or MRI within 42 days prior to registration.
  • No history of seizures, transient ischemic attack or stroke.
  • No clinically significant infections as judged by the treating investigator.
  • No other active cancer except SCLC.
  • No prior treatment with topoisomerase I inhibitor.
Show all 18Show fewer
  • No contraindications to the use of paclitaxel or bevacizumab as per the investigator's clinical judgment.
  • Must not have grade 3 or greater peripheral neuropathy.
  • Must not have had major surgical procedure, open biopsy, or significant traumatic injury within 28 days of being registered for protocol therapy.
  • No anticipation of need for major surgical procedure during the course of the study.
  • Patients may not have had a minor surgical procedure, placement of an access device or fine needle aspiration within 7 days prior to being registered for protocol therapy.
  • No evidence of bleeding diathesis or coagulopathy.
  • No history of deep vein thrombosis or pulmonary embolism.
  • No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin within 10 days prior to registration.
  • Patients must not have been using aspirin (>325 mg/day) or another nonsteroidal anti-inflammatory medications known to inhibit platelet function on a daily basis within 10 days prior to registration on study.
  • Patients must not be using any of the following drugs known to inhibit platelet function within 10 days prior to registration: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal).
  • Patients must not have a current non-healing wound or fracture.
  • Patients must not have a history of or current hemoptysis.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Cancer Care Center of Southern Indiana

    Bloomington, Indiana, 47403

  • Oncology Hematology Associates of SW Indiana

    Evansville, Indiana, 47714

  • Fort Wayne Oncology & Hematology, Inc

    Fort Wayne, Indiana, 46815

  • Medical & Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • Center for Cancer Care at Goshen Health System

    Goshen, Indiana, 46527

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • Quality Cancer Center (MCGOP)

    Indianapolis, Indiana, 46202

  • Community Regional Cancer Center

    Indianapolis, Indiana, 46256

  • Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Medical Consultants, P.C.

    Muncie, Indiana, 47303

  • Center for Cancer Care, Inc., P.C.

    New Albany, Indiana, 47150

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Pennsylvania Oncology-Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • Fox Chase Cancer Center Extramural Research Program

    Rockledge, Pennsylvania, 19046

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Highlands Oncology Group

    Springdale, Arkansas, 72764

  • Siteman Cancer Center

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study

Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC, including in refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response rates and survival when combined with chemotherapy agents compared with the chemotherapy agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in the dose and schedule proposed in this study, improves response rates and progression free survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we will be testing the safety, feasibility, and efficacy of this regimen in patients with chemosensitive relapsed SCLC.

Read the detailed description

OUTLINE: This is a multi-center study.

Paclitaxel 90 mg/m2 IV infusion over 1 hour days 1, 8 and 15 of 28 day cycle

Plus

Bevacizumab 10 mg/kg on days 1 and 15 of 28 day cycle.

  • 1 cycle = 28 days (4 weeks)
  • Disease assessments will be performed per RECIST every other cycle
  • After a minimum of 4 cycles or a maximum of 6 cycles of combination chemotherapy, bevacizumab monotherapy may continue until disease progression or intolerable side effects

ECOG Performance Status 0 or 1

Hematopoietic:

  • White blood cell count > 3,000 mm3
  • Absolute neutrophil count (ANC) > 1,500 mm3
  • Platelet count > 100,000 mm3
  • International normalized ration (INR) of prothrombin time ≤ 1.2
  • PTT no more than 5 seconds longer than the ULN

Hepatic:

  • Bilirubin < 1.5 x ULN
  • Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN

Renal:

  • Urine protein:creatinine ratio <1.0

Cardiovascular:

  • No history of myocardial infarction or angina pectoris/anginal equivalent in the last 6 months. Note: The patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months.
  • No history of uncontrolled congestive heart failure or uncontrolled hypertension
Being tested
Paclitaxel, Bevacizumab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • PaclitaxelDrug

    Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.

  • BevacizumabDrug

    Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle

Study groups in NCT00317200
Study groupRoleWhat they receive
1Active comparatorPaclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.
Receives: Drug: Paclitaxel; Drug: Bevacizumab

What is being measured

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

  1. To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).

    Measured: 18 months

Secondary outcomes (4)

  1. To determine the response rate of the combination of paclitaxel and bevacizumab with chemosensitive SCLC.

    Measured: 18 months

  2. To determine the toxicity of the combination of paclitaxel and bevacizumab in patients with SCLC.

    Measured: 18 months

  3. To determine overall survival.

    Measured: 18 months

  4. To assess VEGF polymorphisms in the study population.

    Measured: 18 months

Timeline

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

  1. First posted24 Apr 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317200
Sponsor's protocol ID
HOG LUN05-99
Status last verified
Apr 2011
First submitted
20 Apr 2006
Last updated
2 May 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Jalal S, Bedano P, Einhorn L, Bhatia S, Ansari R, Bechar N, Koneru K, Govindan R, Wu J, Yu M, Schneider B, Hanna N. Paclitaxel plus bevacizumab in patients with chemosensitive relapsed small cell lung cancer: a safety, feasibility, and efficacy study from the Hoosier Oncology Group. J Thorac Oncol. 2010 Dec;5(12):2008-11. doi: 10.1097/JTO.0b013e3181f77b6e.

    PubMed 21102263

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel and Bevacizumab in people with Small Cell Lung Cancer, run by Hoosier Cancer Research Network at 17 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?

The sponsor lists 6 inclusion and 18 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 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC). (time frame: 18 months). 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 NCT00317200, 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 2 May 2011.

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