Heather Wakelee
A Study of ASA404 or Placebo in Combination With Docetaxel in Second-Line Treatment for (Stage IIIb/IV) Non-Small Cell Lung Cancer (ATTRACT-2)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer
Recruiting Status:
RecruitingStanford Recruiting Status:
Not yet recruitingCondition(s):
Intervention(s):
- Drug: ASA404
- Drug: docetaxel
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Histologically confirmed non-small cell carcinoma of the lung of all histologies. (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable.)
2. Patients who have progressed while on or following a first-line chemotherapy regimen for Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors in first-line will be eligible
3. Age >= 18 years old
4. WHO Performance Status of 0-2
5. Measurable or non-measurable disease per RECIST criteria (PTS-1)
Key Exclusion Criteria:
1. Patients having CNS metastases (Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed).
2. Patients with a history of another primary malignancy <= 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ.
3. Radiotherapy <= 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
4. Major surgery <= 4 weeks prior to randomization (major surgery is defined by the use of general anesthesia). Minor surgery <= 2 weeks prior to randomization. Insertion of a vascular access device is allowed. Patients must have recovered from all surgery-related complications.
5. Treatment with first-line chemotherapy regimen <= 3 weeks prior to randomization (<= 6 weeks for mitomycin and nitrosoureas)
Additional Study Details
Official Title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Docetaxel in Second-Line Treatment of Patients With Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)Anticipated start date:
12/1/2008Lead Sponsor:
NovartisInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Overall survival [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Secondary Outcomes:
- Progression free survival [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Biomarker assessments [ Time Frame: 3 months before end of study ] [ Designated as safety issue: No ]
- Pharmacokinetic assessments [ Time Frame: at end of study ] [ Designated as safety issue: No ]
Total Number to be Enrolled:
900Total Number to be Enrolled at Stanford:
5More Information
Secondary ID(s):
- CASA404A2302
- EUDRACT number: 2008-002309-38
- LUN0032
- NCT00738387
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
5/19/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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