Maximum Tolerated Dose, Safety and Efficacy of Docetaxel... | NCT02127372

NCT02127372

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Interventions

Name	Type	Description	Other Names
Docetaxel, Cisplatin and STI571	Drug	Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given. Phase 1 dose levels are: Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II.	Taxotere Platinol Gleevec Imatinib
Docetaxel	Drug		Taxotere
Cisplatin	Drug		Platinol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase 1 - Maximum Tolerated Dose (MTD) of STI571	To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.	After cycle 1, day 22
Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin	To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.	After cycle 1, day 22
Phase II - Radiographic Response	The percentage of patients with a complete or partial response. Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.	After Cycle 6, approximately 18 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Phase 2: 1 Year Survival	Phase II: Percentage of patients alive 1 year from the start of protocol treatment.	1 year
Change in Gd-MRI Measurement	The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must have histologically or cytologically recurrent, or advanced NSCLC: Stage IV disease; or Stage IIIB due to malignant pleural effusion is allowed- only if successfully pleurodesed.
Tumor tissue slides must express phosophorylated pdgf-rB by IHC.
At least one measurable target lesion as defined by RECIST criteria that has not been irradiated.
No prior chemotherapy treatment for this disease will be allowed. Patients with brain metastasis will have to be, after appropriate treatment, neurologically stable for at least 1-2 weeks (off steroids) prior to study enrollment.
ECOG performance status 0-1.
Meets initial laboratory parameters.
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria

Any prior treatment with a biologic response modifier or chemotherapeutic agent for this disease.
Any concomitant malignancy except non-melanoma skin cancer or in-situ carcinoma of the cervix.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to STI571 and/or docetaxel, or other drugs formulated with polysorbate 80 and/or cisplatin.
Patients with:
- Contrast allergy.
- GI bleed ≤ 1 month from study enrollment.
- Intermittent or chronic oxygen requirements.
- Pulse oximetry <90%.
- Grade 3 dyspnea.
- History of poorly regulated anticoagulation with warfarin.
- Edema or fluid retention grade >1.
- Neuropathy grade ≥1.
Uncontrolled inter-current medical illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, ≤3 months myocardial infarction or cardiac arrhythmia.
Psychiatric illness/social situations that would limit compliance with study requirement or that would prevent informed consent or psychiatric illness/social situations requiring inpatient treatment within the past 3 months.
Any type of hearing impairment.
Known HIV infection.
Receiving other investigational agents.

Name	Affiliation	Role
Gordana Vlahovic, MD, MHS	Duke University	Principal Investigator

Arm/Group Information

ID	Title	Description
FG000	Phase 1	Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
FG001	Phase 2	The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Phase 1	Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Phase 1 - Maximum Tolerated Dose (MTD) of STI571

To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.

One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.

Posted

Number

After cycle 1, day 22

ID	Title	Description
OG000	Phase 1	Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1	Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

ID	Term
D000077143	Docetaxel
D002945	Cisplatin
D000068877	Imatinib Mesylate

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic