Clinical trial NCT01741155: Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer (NSCLC)
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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
* Eastern Cooperative Oncology Group (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 central nervous system (CNS) metastases
* Significant circulatory disorders in the past 6 mo.
* Concomitant treatment with phosphodiesterase inhibitors
* Uncontrolled orthostatic hypotension, asthma or chronic obstructive pulmonary disease (COPD)

Primary outcomes:
measure: Objective Response Rate(ORR) of SPI-1620
timeFrame: Up to 2 years
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: Up to 12 weeks
measure: Progression-free survival(PFS)
timeFrame: 2 years from the start of study treatment
measure: Overall survival (OS)
timeFrame: 2 years from the start of study treatment
measure: Safety of SPI-1620
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc.
state: Ohio
city: Chattanooga
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
Study officials:
References: