A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer - Full Text View

Sponsor:	AmpliMed Corporation
Information provided by:	AmpliMed Corporation
ClinicalTrials.gov Identifier:	NCT00637247

Purpose

The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

Condition	Intervention	Phase
Pancreatic Neoplasms	Drug: imexon in combination with gemcitabine Drug: imexon placebo + gemcitabine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by AmpliMed Corporation:

Primary Outcome Measures:

Overall Survival for the Intent to Treat Population [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective Response Rates of the Two Treatment Arms [ Time Frame: one year ] [ Designated as safety issue: No ]
Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.
Progression Free Survival [ Time Frame: one year ] [ Designated as safety issue: No ]
To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.
One Year Survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]
To evaluate the 1-year survival rates of the two treatment arms.
To Evaluate the Changes in Blood Levels of CA19.9 on the Two Treatment Arms and Whether There is a Relationship to Objective Response, and PFS [ Time Frame: one year ] [ Designated as safety issue: No ]
To Evaluate the OS, ORR, PFS, 1-year Survival, and Changes in CA19.9 of Subjects on the Two Treatment Arms That Completed > 1 Cycle (28 Days) of Protocol Treatment [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	142
Study Start Date:	April 2008
Study Completion Date:	June 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: imexon + gemcitabine imexon + gemcitabine	Drug: imexon in combination with gemcitabine 875 mg/m^2 imexon IV + 1000 mg/m^2 gemcitabine IV Other Name: Amplimexon, Gemzar
Active Comparator: Placebo + gemcitabine Placebo in combination with gemcitabine	Drug: imexon placebo + gemcitabine imexon placebo IV + 1000 mg/m^2 gemcitabine IV Other Name: Gemzar

Eligibility

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

Criteria

Inclusion Criteria:

Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
At least one unidimensional measurable metastatic lesion by contrast enhanced CT scan (or MRI in patients ineligible for contrast enhanced CT) that are outside any prior radiation port.
Age at least 18 years.
ECOG performance status 0 or 1.
No prior chemotherapy or radiation therapy.
Projected life expectancy at least 2 months.
If female, neither pregnant nor lactating.
If of child bearing potential must agree to, and be able to use adequate contraception.
Concomitant disease: No respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life threatening ventricular arrhythmias. No uncompensated CHF or NY Heart Association class 3 or 4 cardiac disease.
No other concurrent active malignancy.
No infection requiring parenteral antibiotic therapy at the start of protocol treatment.
Laboratory values within the following criteria:

Hgb greater than or equal to 9 gm/dL WBC greater than or equal 3,500/mm^3 ANC greater than or equal 1,500/mm^3 Platelet count greater than or equal 100,000/mm^3 Creatinine greater than or equal 2.0 Bilirubin less than or equal to 2.0 Hepatic enzymes (AST, ALT) less than or equal 3 times upper limit of normal (ULN)
G6PD level greater than or equal lower limit of normal (LLN).
Able to render informed consent and follow protocol requirements.

Exclusion Criteria:

Patients with locally advanced, non-metastatic pancreas cancer (Stage III or below).
Age less than 18 years.
ECOG performance status 2 or greater.
Prior anticancer drug therapy for metastatic disease.
Ascites.
Prior abdominal or thoracic surgery < 4 weeks before the start of therapy.
Current or prior brain metastases. Brain MRI or CT required pre-registration only if the patient has CNS symptoms indicating a need for evaluation.
Life expectancy projected less than 2 months.
Pregnancy or lactation.
Unable or unwilling to utilize medically acceptable contraception if of childbearing potential.
Laboratory parameters outside of specified ranges, (see above).
Infection requiring parenteral antibiotics.
NY Heart Association stage 3 or 4 heart disease.
Unable to render informed consent.
Failure to meet any of the eligibility criteria as outlined above.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637247

Show 48 Study Locations

Sponsors and Collaborators

AmpliMed Corporation

Investigators

Study Director:	Evan Hersh, MD	AmpliMed Corporation
Principal Investigator:	Steven Cohen, MD	Fox Chase Cancer Center

More Information

No publications provided

Responsible Party:	Evan Hersh/ Chief Medical Officer, AmpliMed Corporation
ClinicalTrials.gov Identifier:	NCT00637247 History of Changes
Other Study ID Numbers:	AMP-019
Study First Received:	March 10, 2008
Results First Received:	September 17, 2010
Last Updated:	November 30, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AmpliMed Corporation:

pancreatic cancer
metastatic
chemotherapy naive

Additional relevant MeSH terms:

Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012