Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01741155
First received: November 27, 2012
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC and to determine the safety of SPI-1620 when administered in combination with docetaxel.


Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: SPI-1620 & Docetaxel
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Objective Response Rate(ORR) of SPI-1620 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC


Secondary Outcome Measures:
  • Duration of Response (DoR) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    only in Randomized Part.

  • Progression-free survival(PFS) [ Time Frame: 2 years from the start of study treatment ] [ Designated as safety issue: No ]
    only in Randomized Part

  • Overall survival (OS) [ Time Frame: 2 years from the start of study treatment ] [ Designated as safety issue: No ]
  • Safety of SPI-1620 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed.


Estimated Enrollment: 227
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPI-1620 & Docetaxel

Single Arm and Randomized Part:

SPI-1620: 11μg/m2 Docetaxel: 75 mg/m2

Drug: SPI-1620 & Docetaxel

Single Arm & Randomized Part:

On Day 1, the patient will receive standard docetaxel premedication followed by SPI-1620 11 μg/m2 administered intravenously over one minute. Patients will receive docetaxel 10 (±2) minutes following the infusion of SPI-1620. Docetaxel dose is 75 mg/m2 infusion. Patients will continue to receive SPI-1620 plus docetaxel once every 3 weeks until disease progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm Part. If 6 or more responses are observed in this group then the Randomized Part will be initiated. About 100 patient in the experimental arm will receive SPI-1620 & Docetaxel

Other Name: Docetaxel (Taxotere)
Active Comparator: Docetaxel
Randomized Part only Docetaxel: 75 mg/m2 on Day 1 in 3-week cycles
Drug: Docetaxel

Randomized Part-Control Arm (100 patient):

On Day 1 the patient will receive standard docetaxel premedication followed by docetaxel 75 mg/m2 by infusion over 1 hour. Patients will continue to receive docetaxel once every 3 weeks until disease progression or intolerable toxicity.

Other Name: Taxotere

Detailed Description:

This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part will be initiated.

In the Randomized Part approximately 200 patients (100 per arm) will be randomized to receive SPI-1620 plus docetaxel or docetaxel alone.

In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or intolerable toxicity.

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC that has failed one prior platinum-containing chemotherapy
  • Measurable disease as per RECIST v. 1.1
  • ECOG performance status of 0, 1 or 2
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • More than one prior chemotherapy regimen for metastatic NSCLC
  • Known, uncontrolled CNS metastases
  • Significant circulatory disorders in the past 6 mo.
  • Concomitant treatment with phosphodiesterase inhibitors
  • Uncontrolled orthostatic hypotension, asthma or COPD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741155

Locations
United States, Ohio
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Tennessee Oncology PLLC
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Mi Rim Choi, MD Spectrum Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01741155     History of Changes
Other Study ID Numbers: SPI-1620-12-201
Study First Received: November 27, 2012
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

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
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014