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Lung CancerPhase 1/2NCT00547443

Sorafenib and High-Dose Carboplatin, Paclitaxel, and External-Beam Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

A Phase 1/2 study testing carboplatin, paclitaxel and sorafenib tosylate in people with Lung Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, paclitaxel and sorafenib tosylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Jul 2007to Jul 2009
Phase
Phase 1/2
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically documented non-small cell lung cancer (NSCLC)
  • Any of the following subtypes allowed:
  • Adenocarcinoma (including bronchoalveolar cell)
  • Squamous cell carcinoma
  • Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
  • Poorly differentiated (not otherwise specified) NSCLC
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  • No metastasis (patients must be M0)
  • Stage IIIA (T1 or T2 with N2 or T3N1-2) or stage IIIB (T4 with any N or any T with N2 or N3) disease
  • Measurable disease
  • Tumors adjacent to a vertebral body are allowed as long as all gross disease can be encompassed in the radiation boost field
  • The boost volume must be limited to < 50% of the ipsilateral lung volume
  • Pleural effusion that is a transudate, cytologically negative, and nonbloody allowed if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy
  • Pleural effusions seen on the chest CT but too small to tap allowed
  • Zubrod performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL (prior to transfusions)
  • Total bilirubin ≤ 1.5 mg/dL
  • AST or ALT ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Glucose ≤ 2 times ULN
  • Creatinine ≤ 2.0 mg/dL
  • FEV_1 ≥ 1,200 mL
  • Weight loss ≤ 10% over the past 3 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women of childbearing potential and male participants who are unwilling or unable to use an acceptable method of contraception throughout the study and for 4 weeks after completion of treatment or those who are using a prohibited contraceptive method
  • INR < 1.5 or a PT/PTT within normal limits
  • Recovered from exploratory thoracotomy
  • Concurrent anti-coagulation treatment with an agent such as warfarin or heparin allowed provided INR or PT/PTT requirements are met

Who cannot join

  • Totally resected tumors
  • Exudative, bloody, or cytologically malignant effusions
  • Known brain metastasis
  • Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
  • PATIENT CHARACTERISTICS:
  • Known allergy to murine proteins or Cremophor EL
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  • Active pulmonary infection not responsive to conventional antibiotics
  • History of severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations over the past year
  • Cardiac disease including any of the following:
  • Congestive heart failure > class II NYHA
  • Unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months)
  • Myocardial infarction within the past 6 months
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Patients with neuropathy > grade 1
  • Evidence of malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancer
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
  • Known HIV infection or chronic hepatitis B
  • Active clinically serious infection > CTCAE grade 2
  • Thrombolic or embolic events, such as a cerebrovascular accident including transient ischemic attacks, within the past 6 months
  • Pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
  • Any other hemorrhage or bleeding event ≥ CTCAE Grade 3 within the past 4 weeks
  • Serious nonhealing wound, ulcer, or bone fracture
  • Evidence or history of bleeding diathesis or coagulopathy
  • Known or suspected allergy to sorafenib tosylate or any agent given in the course of this trial
  • Any condition that impairs patient's ability to swallow whole pills
  • Any malabsorption problem
  • Significant traumatic injury within the past 4 weeks
  • PRIOR CONCURRENT THERAPY:
  • Prior systemic chemotherapy for lung cancer and/or thoracic/neck radiotherapy for any reason
  • Prior surgical resection of present cancer
  • Prior therapy with any molecular-targeted drugs (for lung cancer)
  • Currently participating in other phase III therapeutic clinical trials and/or who have participated in other phase III therapeutic clinical trials in the previous 30 days
  • Major surgery or open biopsy within the past 4 weeks
  • Concurrent Hypericum perforatum (St. John's wort) or rifampin (rifampicin)
  • Other concurrent anticancer drugs, including hormonal, immunotherapeutic, or chemotherapeutic agents
  • Steroids for acute symptom management, adrenal failure, septic shock, or as antiemetics allowed
  • Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
  • Amifostine concurrently with radiotherapy or within 3 months of completion of radiotherapy
  • Concurrent colony-stimulating factors (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF])

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Arlington Cancer Center - Arlington

    Arlington, Texas, 76012-2510

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

Other trials in United States

About this study

Official title: A Randomized Phase I/II Study Of Sorafenib In Combination With High Does Chemoradiation In Patients With Stage IIIA/B Non-small Cell Lung Cancer (NSCLC)

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving sorafenib together with high-dose chemotherapy and external-beam radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of sorafenib when given together with high-dose carboplatin, paclitaxel, and external-beam radiation therapy in treating patients with stage III non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the median survival from randomization for patients receiving carboplatin and paclitaxel with high-dose radiation therapy (HDRT) or same regimen with sorafenib tosylate.

Secondary

  • To determine the overall response rate, failure-free survival, and survival for patients receiving carboplatin/paclitaxel with 74 Gy HDRT or same regimen with sorafenib tosylate.
  • To determine the feasibility of concurrent sorafenib tosylate and chemoradiation as measured by safety (the rate of grade 3 or higher radiation related esophagitis or pulmonary toxicity or chemotherapy related grade 4 hematological or other non-hematological toxicities occurring within 60 days of the start of treatment) and compliance (the completion of the treatment regimen with no more than minor variations).
  • To correlate outcomes (survival, toxicity, quality of life) with biological parameters.

OUTLINE: This is a multicenter study.

  • Phase I:
  • Chemoradiotherapy: Patients receive paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats weekly for 7 weeks. Patients undergo concurrent high-dose external beam radiotherapy (HDRT) 5 days a week for 7.5 weeks. Cohorts of patients also receive escalating doses of oral sorafenib tosylate twice daily for 7 weeks.
  • Consolidation therapy: Beginning at week 11, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 weeks. Patients also receive oral sorafenib tosylate at the maximum tolerated dose (MTD) twice daily.
  • Maintenance: Patients receive oral sorafenib tosylate twice daily at the MTD.
  • Phase II: Patients are randomized to 1 of 2 treatment arms.
  • Arm I:
  • Chemoradiotherapy: Patients receive paclitaxel, carboplatin, and HDRT as in phase I.
  • Consolidation therapy: Patients receive paclitaxel and carboplatin as in phase I.
  • Arm II:
  • Chemoradiotherapy: Patients receive paclitaxel, carboplatin, and HDRT as in phase I. Patients also receive oral sorafenib tosylate as in phase I at the MTD.
  • Consolidation therapy: Patients receive paclitaxel, carboplatin, and sorafenib tosylate at the MTD as in phase I.
  • Maintenance: Patients receive sorafenib tosylate at the MTD as in phase I. After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for 2 years.
Conditions
Lung Cancer
Being tested
carboplatin, paclitaxel, sorafenib tosylate, radiation therapy
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer, bronchoalveolar cell lung cancer, adenosquamous cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

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

  • carboplatinDrug

    Given IV

  • paclitaxelDrug

    Given IV

  • sorafenib tosylateDrug

    Given orally

  • radiation therapyRadiation

    Given 5 days a week for 7.5 weeks

Study groups in NCT00547443
Study groupRoleWhat they receive
Arm IActive comparatorPatients receive chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose external beam radiotherapy (HDRT) as in phase I. Patients also receive consolidation therapy comprising paclitaxel and carboplatin as in phase I.
Receives: Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy
Arm IIExperimentalPatients receive chemoradiotherapy comprising paclitaxel, carboplatin, and HDRT as in phase I. Patients also receive consolidation therapy comprising paclitaxel, carboplatin, and sorafenib tosylate at the MTD as in phase I, as well as maintenance therapy comprising sorafenib tosylate at the MTD as in phase I.
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: sorafenib tosylate; Radiation: radiation therapy

What is being measured

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

  1. Median survival

    To determine the median survival from randomization for patients receiving carboplatin / paclitaxel with high dose radiation therapy or same regimen with Sorafenib.

    Measured: Mean 24-Months

Secondary outcomes (1)

  1. Progression-free survival

    To determine the overall response rate, failure-free survival and survival for patients receiving carboplatin / paclitaxel with high dose radiation therapy or same regimen with Sorafenib.

    Measured: Mean 24-Months

Timeline

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

  1. First posted22 Oct 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2009
  4. Study completionJul 2009

Why it stopped: Withdrawn as the sponsor has stopped the drug for NSCLC population

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00547443
Sponsor's protocol ID
SCCC-03507
Other IDs
SCCC-052007-068, BAYER-SCCC-052007-068, CDR0000571535
Status last verified
Jan 2019
First submitted
19 Oct 2007
Last updated
10 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing carboplatin, paclitaxel and sorafenib tosylate in people with Lung Cancer, run by University of Texas Southwestern Medical Center 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?

The sponsor lists 30 inclusion and 39 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: withdrawn, as of the sponsor's last update on 10 Jan 2019. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

Median survival (time frame: Mean 24-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 NCT00547443.

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 Jan 2019.

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