A Randomized Study of Amplimexon 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 + gemcitabine Drug: imexon placebo + gemcitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

To compare the overall survival durations of the two treatment arms. [ Time Frame: one year ] [ Designated as safety issue: No ]
To evaluate and compare the tolerability and toxicity of the two treatment arms. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare the objective response rates of the two treatment arms. [ Time Frame: one year ] [ Designated as safety issue: No ]
To compare the progression free survival (PFS) of the two treatment arms. [ Time Frame: one year ] [ Designated as safety issue: No ]
To evaluate the 1-year survival rates of the two treatment arms. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
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 ]

Estimated Enrollment:	124
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Amplimexon + gemcitabine	Drug: imexon + gemcitabine 875 mg/m2 imexon IV + 1000 mg/m2 gemcitabine IV
B: Active Comparator Amplimexon placebo + gemcitabine	Drug: imexon placebo + gemcitabine imexon placebo IV + 1000 mg/m2 gemcitabine IV

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 (Appendix C, Sections 6.3 and 6.4).
Age at least 18 years.
ECOG performance status 0 or 1 (Appendix D).
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 (Appendix D).
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/mm3 ANC greater than or equal 1,500/mm3 Platelet count greater than or equal 100,000/mm3 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:	AmpliMed Corporation ( Tom Williams/ Chief Medical Officer )
Study ID Numbers:	AMP-019
Study First Received:	March 10, 2008
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00637247 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AmpliMed Corporation:

pancreatic cancer
metastatic
chemotherapy naive

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009