Safety of DAVANAT With and Without 5-Fluorouracil in Patients With Solid Tumors - Full Text View

Sponsored by:	Pro-Pharmaceuticals
Information provided by:	Pro-Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00054977

Purpose

This is a Phase I, multi-center study of a carbohydrate (DAVANAT) which has been shown to increase the anti-tumor activity of 5-fluorouracil in mice.

5-Fluorouracil is a chemotherapy drug commonly used in cancer patients. Patients with different type of solid tumors who have failed standard, approved treatments can be enrolled in the study. Different doses of DAVANAT will be given alone in Cycle 1, and in combination with 5-fluorouracil in cycle 2.

Patients will be on study for approximately 90 days. The main reason for doing the study is to determine the safety of the drug given alone and in combination. In patients who have cancer that can be measured by CT scan, it will be determined whether the tumors change in size (get bigger, smaller or stay the same)after Cycle 2.

Condition	Intervention	Phase
Colorectal Cancer Lung Cancer Breast Cancer Head and Neck Cancer Prostate Cancer	Drug: DAVANAT Drug: 5-fluorouracil	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Open-Label Study to Evaluate the Safety and Tolerability of Escalating Doses of DAVANAT (A Galactomannan Derivative) in the Presence and Absence of 5-Fluorouracil (5-FU) in Subjects With Advanced Solid Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Prostate Cancer

Drug Information available for: Fluorouracil

U.S. FDA Resources

Further study details as provided by Pro-Pharmaceuticals:

Primary Outcome Measures:

Safety

Secondary Outcome Measures:

Tumor progression

Estimated Enrollment:	40
Study Start Date:	February 2003
Estimated Study Completion Date:	March 2005

Eligibility

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

Criteria

Inclusion Criteria

The subject is able to give informed consent to participate in this trial (including all procedures and follow-up visits).
The subject is male or female at least 18 years of age.
The subject has a documented histologic or cytologic recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value.
Subjects must have completed previous therapy (chemotherapeutic agents or other therapies including radiation) at least 4 weeks prior to study entry.
Following major surgery (e.g. laparotomy), > 4 weeks must have elapsed and subjects must have recovered from effects.
Following minor surgery (does not include insertion of vascular access device), > 2 weeks must have elapsed.
ECOG performance status of 0-2.
The subject has a life expectancy of at least 12 weeks.
Female subjects must be post-menopausal, surgically sterile, or using effective contraception.

Laboratory values prior to administration of study drug:

If female and not post-menopausal, the subject has a negative pregnancy test.
Liver function studies: AST and ALT < 2.5 times the upper limit of normal (ULN); total bilirubin < 1.5
Hematopoietic parameters: WBC > 3000 per mm3; Granulocyte count > 1,500 per mm3; Platelet count > 100,000 per mm3
Renal: Creatinine < or = ULN
Pulmonary: Dlco > or = 60% of predicted

Exclusion Criteria

If female, the subject is pregnant or breast feeding.
Central nervous system (CNS) metastases or primary CNS tumors.
The subject has a known hypersensitivity to DAVANAT™ or any of its components.
The subject has congestive heart failure or any other medical condition that could be adversely affected by intravenous infusion of up to approximately 200 mL of fluid over 60 minutes.
The subject is currently abusing alcohol and/or illicit drugs.
The subject has other significant medical, psychiatric, or social conditions which, in the investigators’ opinion, may compromise the subject's safety in participating in this study.
In the investigators’ judgment, the subject would be unreliable in adhering to the study visit schedule or other study requirements.
The subject is currently enrolled in a clinical trial or has participated in a clinical trial within the 30 days prior to entry into this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054977

Locations

United States, Florida
Florida Oncology Associates
Jacksonville, Florida, United States, 32207
United States, Louisiana
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Pro-Pharmaceuticals

Investigators

Study Director:

Marilyn C Pike, M.D., Ph.D.

Consultant to Pro-Pharmaceuticals, Inc.

More Information

No publications provided

Study ID Numbers:	DAVFU-001
Study First Received:	February 14, 2003
Last Updated:	December 18, 2006
ClinicalTrials.gov Identifier:	NCT00054977 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pro-Pharmaceuticals:

cancer
tumor
5-fluorouracil
carbohydrate

Study placed in the following topic categories:

Thoracic Neoplasms
Antimetabolites
Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Gastrointestinal Diseases
Colonic Diseases
Urogenital Neoplasms
Rectal Diseases
Respiratory Tract Diseases
Lung Neoplasms
Breast Diseases
Digestive System Neoplasms

Skin Diseases
Breast Neoplasms
Intestinal Diseases
Genital Diseases, Male
Immunosuppressive Agents
Intestinal Neoplasms
Digestive System Diseases
Head and Neck Neoplasms
Lung Diseases
Fluorouracil
Gastrointestinal Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Thoracic Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Urogenital Neoplasms
Rectal Diseases
Neoplasms by Site
Respiratory Tract Diseases

Lung Neoplasms
Therapeutic Uses
Breast Diseases
Respiratory Tract Neoplasms
Digestive System Neoplasms
Skin Diseases
Breast Neoplasms
Intestinal Diseases
Genital Diseases, Male
Immunosuppressive Agents
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Digestive System Diseases
Fluorouracil

ClinicalTrials.gov processed this record on July 02, 2009