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 - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00544648

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: paclitaxel albumin-stabilized nanoparticle formulation Procedure: 3-dimensional conformal radiation therapy	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
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)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose (phase I) [ Designated as safety issue: Yes ]
Progression-free survival (phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival (phase I) [ Designated as safety issue: No ]
Survival (phase I) [ Designated as safety issue: No ]
Response rate (phase I) [ Designated as safety issue: No ]
Secreted protein acidic and rich in cysteine (SPARC) gene expression [ Designated as safety issue: No ]
Overall survival (phase II) [ Designated as safety issue: No ]
Safety and tolerability [ Designated as safety issue: Yes ]
Dose-limiting toxicity (phase I) [ Designated as safety issue: Yes ]

Estimated Enrollment:	98
Study Start Date:	November 2007
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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

DISEASE CHARACTERISTICS:

Inclusion criteria:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting all of the following criteria:
- Non-metastatic, inoperable disease
- Stage IIIA or IIIB disease
Must have ≥ 1 site of unidirectionally measurable disease
No evidence of malignant pleural effusion

Exclusion criteria:

Wet stage IIIB or stage IV NSCLC
Brain metastasis

PATIENT CHARACTERISTICS:

Inclusion criteria:

ECOG performance status 0-1
ANC ≥ 1,500/mm^3
Hemoglobin ≥ 9.0 g/dL
Creatinine ≤ 1.5 mg/dL or creatinine clearance > 45 mL/min
Platelet count > 100,000/mm^3
Total bilirubin normal
AST and ALT ≤ 2.5 x upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 x ULN
FEV_1 > 800 mL
Negative pregnancy test
Fertile patients must use effective contraception prior to, during, and for at least 3 months after completion of study therapy

Exclusion criteria:

Known hypersensitivity to carboplatin or paclitaxel albumin-stabilized nanoparticle formulation
Peripheral neuropathy ≥ grade 2
Any uncontrolled, clinically significant medical or psychiatric disorder
Pregnant or nursing women
At least 10% weight loss over the past 3 months
Any concurrent malignancy

PRIOR CONCURRENT THERAPY:

No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for treatment of NSCLC
More than 3 weeks since prior exploratory thoracotomy
No prior chemotherapy or radiotherapy to the chest
No other concurrent chemotherapy, immunotherapy, or antitumor hormonal therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544648

Locations

United States, Kentucky
Mitchell Memorial Cancer Center at Owensboro Medical Health System	Recruiting
Owensboro, Kentucky, United States, 42303
Contact: Dattatraya S. Prajapati 270-688-1900
Purchase Cancer Group - Paducah	Recruiting
Paducah, Kentucky, United States, 42002
Contact: Contact Person 270-554-0011
United States, Tennessee
Erlanger Cancer Center at Erlanger Hospital - Baroness	Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Clinical Trials Office - Erlanger Cancer Center 423-778-6947
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Vicki Keedy 615-591-9890
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Vicki Keedy 615-322-4967

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Alan B. Sandler, MD	Vanderbilt-Ingram Cancer Center
Principal Investigator:	Vicki Keedy, MD	Vanderbilt-Ingram Cancer Center
Principal Investigator:	Bo Lu, MD, PhD	Vanderbilt-Ingram Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Vanderbilt-Ingram Cancer Center ( Alan B. Sandler )
Study ID Numbers:	CDR0000573126, VU-VICC-THO-0746
Study First Received:	October 13, 2007
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00544648
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009