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

This study has been terminated.
(funding unavailable)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Vicki Keedy, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00544648
First received: October 13, 2007
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose

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

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving paclitaxel albumin-stabilized nanoparticle formulation together with carboplatin and radiation therapy and to see how well it works in treating patients with stage III non-small-cell lung cancer that cannot be removed by surgery.


Condition Intervention Phase
Lung Cancer
 Drug: carboplatin
Drug: Nab-Paclitaxel
Radiation: Radiation therapy
Radiation: Radiation Therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VICC THO 0746 - A Phase I/II Study of Nab-Paclitaxel and Carboplatin With Concurrent Radiation Therapy for Unresectable Stage III Non-Small-Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose (phase I) [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
  • Progression-free survival (phase II) [ Time Frame: date on study to the date of measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (phase I) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Survival (phase I) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Response rate (phase I) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Secreted protein acidic and rich in cysteine (SPARC) gene expression [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Overall survival (phase II) [ Time Frame: date on study to date of death from any cause ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
  • Dose-limiting toxicity (phase I) [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: November 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Nab-Paclitaxel+ carboplatin + radiation
 Drug: carboplatin
(AUC 2) through a vein over 30 minutes following nab -paclitaxel, once/ week x 7 weeks
Drug: Nab-Paclitaxel
Phase I: beginning at 40 mg/m2 through a vein over 30 minutes once/week X 7weeks Phase II: Maximum tolerated dose through a vein over 30 minutes once/week X 7 weeks
Radiation: Radiation therapy
3D conformal radiotherapy or Intensity-Modulated Radiation Therapy (IMRT), 2.0 Gy per day x 5 days per week for 33 days during Weeks 1-7 ; Total Dose = 66 Gy
Radiation: Radiation Therapy
3D conformal radiotherapy or intensity-modulated radiation therapy (IMRT), 2.0 Gy per day x 5 days per week for 33 days during Weeks 1-7 ; Total Dose = 66 Gy

Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation when combined concurrently with carboplatin and radiation followed by two courses of paclitaxel albumin-stabilized nanoparticle formulation with carboplatin as consolidation. (Phase I)
  • To evaluate the progression-free survival in patients with stage III unresectable non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, and radiotherapy followed by two courses of paclitaxel albumin-stabilized nanoparticle formulation with carboplatin as consolidation. (Phase II)

Secondary

  • To assess safety and tolerability and identify dose-limiting toxicities in patients receiving paclitaxel albumin-stabilized nanoparticle formulation combined concurrently with carboplatin and radiotherapy. (Phase I)
  • To assess progression-free survival, response rates, and survival. (Phase I)
  • To assess overall survival and response rates in all patients treated on this study. (Phase II)
  • To assess the safety and tolerability of patients receiving paclitaxel albumin-stabilized nanoparticle formulation combined concurrently with carboplatin and radiotherapy followed by two courses of paclitaxel albumin-stabilized nanoparticle formulation/carboplatin as consolidation. (Phase II)
  • To analyze tumor specimens for the secreted protein acidic and rich in cysteine (SPARC) gene expression.

OUTLINE: This is a multicenter study.

  • Phase I:

    • Concurrent chemoradiotherapy: Patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. They also receive conformal radiotherapy once daily 5 days a week on days 1-5 in weeks 1-7. Patients are evaluated between weeks 8-10. Patients with disease progression are removed from study. Patients with stable disease, partial response, or complete response proceed to consolidation chemotherapy 3 weeks after completion of chemoradiotherapy.
    • Consolidation chemotherapy: Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats ever 21 days for up to 2 courses.
  • Phase II: Patients receive concurrent chemoradiotherapy at the MTD of nab-paclitaxel followed by consolidation chemotherapy as in phase I.

Paraffin embedded blocks from previously performed biopsies or resections from consenting patients are obtained for SPARC gene expression.

After completion of study treatment, patients are followed at 2 months, every 3 months for 2 years, every 4 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 98 patients (15 patients for phase I and 83 patients for phase II) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Phase I and Phase II Patients:

  • Patients must voluntarily sign and date an informed consent before the initiation of any study procedures
  • Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion
  • Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC
  • Patients must have at least one site of unidirectionally measurable disease as defined by RECIST criteria
  • Patients must be ≥ 3 weeks from a formal exploratory thoracotomy
  • Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry
  • Patients must be ≥ 18 years of age
  • Patients must have an ECOG performance status of 0 or 1
  • Women of childbearing potential must have a negative baseline serum pregnancy or a negative urine pregnancy test within 7 days prior to Week 1, Day 1 and must not be breast feeding.
  • Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy.

  • Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:

    • Absolute neutrophil count (ANC) ≥1,500/mm3
    • Hemoglobin ≥ 9.0 gm/dL
    • Serum Creatinine ≤1.5mg/dl
    • Platelets > 100,000/mm3
    • Total bilirubin ≤ upper limit of normal
    • AST and ALT < 2.5 X upper limit of normal
    • Alkaline phosphatase < 2.5 X upper limit of normal
    • Calculated CrCl > 45 ml/min (via Cockroft-Gault formula)
    • Forced expiratory volume in 1 second (FEV 1) > 800 ml

Exclusion Criteria for Phase I and Phase II Patients:

  • Known hypersensitivity to carboplatin or nab-paclitaxel
  • Peripheral neuropathy Grade ≥ 2
  • Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC
  • Previous chemotherapy or radiation therapy to the chest
  • Any concomitant malignancy or brain metastasis
  • Any uncontrolled, clinically significant medical or psychiatric disorder
  • Pregnant or nursing women
  • A greater than or equal to 10% weight loss over the past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544648

Locations
United States, Kentucky
Purchase Cancer Group - Paducah
Paducah, Kentucky, United States, 42002
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Tennessee
Erlanger Cancer Center at Erlanger Hospital - Baroness
Chattanooga, Tennessee, United States, 37403
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vicki Keedy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Vicki Keedy, Assistant Professor of Medicine; Clinical Director, Sarcoma Program; Assistant Medical Director, Clinical Trials Shared Resource; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00544648     History of Changes
Other Study ID Numbers: VICC THO 0746, P30CA068485, VU-VICC-THO-0746
Study First Received: October 13, 2007
Last Updated: November 16, 2011
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 17, 2012