A Safety and Efficacy Trial of Amplimexon Plus Taxotere in Metastatic Non-Small Cell Lung Cancer
This study has been withdrawn prior to enrollment.
(Study cancelled prior to start due to change in company priorities.)
Information provided by:
First received: June 11, 2008
Last updated: June 24, 2010
Last verified: June 2010
Protocol AMP-024 is a Phase 2 study of imexon plus docetaxel for patients with previously treated lung cancer that has spread in the body. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for this cancer. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine if the combination of imexon plus docetaxel is safe and effective.
Carcinoma, Non-Small-Cell Lung
Drug: Imexon + docetaxel
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multicenter, Phase II Trial of the Safety and Efficacy of Amplimexon® (Imexon for Injection) in Combination With Taxotere® (Docetaxel) for Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)
Primary Outcome Measures:
- Overall response rates (CR + PR) in subjects with measurable disease will be determined by RECIST methodology. [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival (PFS), as measured from the date of registration to the date of recorded disease progression (PD) or death from any cause. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Overall survival, as measured from the date of registration to the date of death from any cause. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Stable disease rate at 2 months. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Survival at 1-year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Duration of response and stable disease. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Safety parameters (AEs, laboratory parameters, concomitant medication, study drug exposure, drug related toxicities, etc.) [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
Experimental: Stage 1/2
Imexon plus docetaxel
Drug: Imexon + docetaxel
Imexon at 1300 mg/m2 days 1-5 Docetaxel at 75 mg/m2 day 1
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects with histologically or cytologically confirmed NSCLC.
Subject with metastatic disease (Appendix D) who have received no more than 2 prior chemotherapy regimens for their metastatic disease.
- Adjuvant chemotherapy is considered one prior regimen.
- Immunological and targeted agents such as bevacizumab, erlotinib or gefitinib are considered prior regimens.
- Subjects must have at least one measurable lesion by RECIST criteria (Appendix C). If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD, and if the only target lesion is a single lesion, a cytological or histological confirmation of NSCLC is required.
- Resolution of all chemotherapy or radiotherapy-related toxicities to CTCAE grade 1 or lower, except for stable sensory neuropathy of < grade 2 and/or alopecia.
- Men and women age > 18 years.
- ECOG performance status of 0 - 1 (Appendix E).
- Not pregnant nor lactating.
- If of child bearing potential must be able and agree to use adequate contraception.
Adequate renal function defined by:
- serum creatinine level < 2.0 mg/dL.
- G6PD (quantitative) greater than or equal to the lower limit of normal.
Adequate hematologic function defined by:
- absolute neutrophil count (ANC) >1,500/mm³, and
- platelet count > 100,000/mm³, and
- hemoglobin level > 9 g/dL.
Adequate hepatic function defined by:
- total bilirubin level < ULN, and
- AST and ALT levels < 1.5 x ULN
- Alkaline phosphatase < 2.5x ULN
- Prior brain metastasis are allowed but must have been treated and controlled for > 1 month prior and be off steroids.
- Subjects willing and able to comply with the study protocol for the duration of the study.
- Able to render written informed consent and to follow protocol requirements.
- Subjects who have received previous treatment with docetaxel.
- Subjects who have received chemotherapy or radiation treatments within 4 weeks of study treatment start.
- Prior high dose chemotherapy with hematopoietic stem cell rescue within the past two years.
- Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen and/or the medical management of recurrent pleural effusions.
- Subjects with meningeal carcinomatosis.
- Women who are pregnant or breast-feeding, women of child bearing potential (WOCBP) with either a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) or no pregnancy test; WOCBP unless (1) surgically sterile (hysterectomy, or bilateral oophorectomy) or (2) not using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Severe or uncontrolled intercurrent infection or other illness.
- Significant cardiovascular disease including but not limited to a history of congestive heart failure of > NYHA grade II (Appendix E), unstable angina or a myocardial infarction within the past six months, or serious and uncontrolled arrhythmia.
- Subjects with organ allografts.
- Subjects who have had a prior malignancy, other than carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder cancer unless the prior malignancy was diagnosed and definitively treated > 5 years previously with no subsequent evidence of recurrence.
- Subjects with pre-existing neuropathy > CTCAE Grade 2.
- Subjects with other significant disease or disorders that, in the opinion of the Investigator, would exclude the subject from the study
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00697060
|USC Norris Cotton Cancer Center
|Los Angeles, California, United States |
|Massachusetts General Hospital
|Boston, Massachusetts, United States |
|Mary Crowley Research Center
|Dallas, Texas, United States |
||Evan Hersh, MD
No publications provided
||Evan Hersh, AmpliMed
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 11, 2008
||June 24, 2010
||United States: Food and Drug Administration
Keywords provided by AmpliMed Corporation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Molecular Mechanisms of Pharmacological Action