We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553462
First Posted: November 5, 2007
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
November 2, 2007
November 5, 2007
November 23, 2016
January 20, 2017
January 20, 2017
March 2008
January 2014   (Final data collection date for primary outcome measure)
Overall Survival at 12 Months [ Time Frame: At 12 months ]
Percentage of participants who were alive at 12 months.
Overall Survival at 12 Months
Complete list of historical versions of study NCT00553462 on ClinicalTrials.gov Archive Site
  • Response Rate [ Time Frame: Duration of study (up to 2 years) ]

    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

    • Complete Response (CR): disappearance of all target lesions;
    • Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
    • Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
    • Stable Disease (SD): small changes that do not meet above criteria.

    Response rate is reported as the percentage of participants who achieved each response.

  • Progression-free Survival [ Time Frame: Duration of study (up to 2 years) ]
    Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.
  • Response Rate
  • Progression-free Survival
Not Provided
Not Provided
 
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, 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. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

  • To determine the activity of induction chemotherapy comprising carboplatin and paclitaxel albumin-stabilized nanoparticle formulation followed by concurrent thoracic radiotherapy and erlotinib hydrochloride in patients with poor-risk, unresectable stage IIIA or IIIB non-small cell lung cancer.

Secondary

  • To determine the response rate and progression-free survival of these patients.

OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study. Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
  • Drug: erlotinib hydrochloride
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Radiation: radiation therapy
Experimental: paclitaxel + carboplatin + radiation + erlotinib

Patients receive paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease progression outside of the chest after induction therapy are removed from study.

Patients with intrathoracic disease progression within the potential radiation field may continue protocol therapy at the discretion of the Study Chair. Patients with no disease progression outside the planned radiation field (either regional or distant) proceed to concurrent erlotinib hydrochloride and radiotherapy.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily. Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions) in the absence of rapid disease progression outside of the chest or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, and then every 6 months for up to 2 years

Interventions:
  • Drug: carboplatin
  • Drug: erlotinib hydrochloride
  • Drug: paclitaxel albumin-stabilized nanoparticle formulation
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
78
Not Provided
January 2014   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologies:

    • Squamous cell carcinoma
    • Adenocarcinoma (including bronchoalveolar cell)
    • Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
  • Must meet the following criteria:

    • T1-3 with N2 and selected N3*
    • T4 with N0, N1, N2 and selected N3*
    • M0 (no M1 patients) NOTE: *Patients with contralateral mediastinal disease (i.e., N3) are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria. Patients with ipsilateral scalene or supraclavicular disease are also eligible. Patients with contralateral hilar or supraclavicular node involvement are not eligible.
  • Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

    • Nonmeasurable lesions include the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusion
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in a previously irradiated area
  • Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist
  • Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months
  • Patients with tumors adjacent to a vertebral body are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria
  • Pleural effusions meeting the following criteria allowed:

    • Effusion is transudate, cytologically negative, and non-bloody
    • Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too small to tap
    • Effusion appears only after a thoracotomy or other invasive thoracic procedure was attempted

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • Granulocytes ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Creatinine ≤ 1.5 x upper limit of normal (ULN)
  • AST < 2 x ULN
  • Bilirubin ≤ ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for NSCLC
  • At least 2 weeks since formal exploratory thoracotomy
  • No concurrent administration of sucralfate suspension and erlotinib hydrochloride
  • No concurrent intensity-modulated radiotherapy
  • No concurrent hormones or other chemotherapeutic agents except steroids given for adrenal failure, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic
  • No concurrent palliative radiotherapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00553462
CALGB-30605
CALGB-30605
CDR0000573832 ( Registry Identifier: NCI Physician Data Query )
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Rogerio Lilenbaum, MD Cleveland Clinic Florida
Alliance for Clinical Trials in Oncology
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP