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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)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (phase I)

Outcome Time Frame:

7 weeks

Safety Issue:

Yes

Principal Investigator

Vicki Keedy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC THO 0746

NCT ID:

NCT00544648

Start Date:

November 2007

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Oregon Health Sciences UniversityPortland, Oregon  
Erlanger Cancer Center at Erlanger Hospital - BaronessChattanooga, Tennessee  37403
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064
Purchase Cancer Group - PaducahPaducah, Kentucky  42001