Trial record 11 of 136 for:
breast,cancer,prevention | Open Studies
Study of 0.1% Uracil Ointment (1UO) Ointment for the Prevention of Hand-Foot Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Cahaba Pharmaceuticals.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Cahaba Pharmaceuticals
Information provided by:
Cahaba Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01100463
First received: April 6, 2010
Last updated: April 8, 2010
Last verified: April 2010
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Purpose
The purpose of this research study is to see if combining uracil ointment (1UO) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects 1UO and capecitabine may have in patients with metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Palmar-Plantar Erythrodysesthesia Breast Cancer |
Drug: Ointment Drug: 0.1% Uracil Ointment |
Phase 1 Phase 2 |
| 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: Prevention |
| Official Title: | A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of 0.1% Uracil Ointment (1UO)in the Prevention of Hand-Foot Syndrome (HFS) in Patients With Metastatic Breast Cancer Treated With Capecitabine |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Capecitabine
U.S. FDA Resources
Further study details as provided by Cahaba Pharmaceuticals:
Primary Outcome Measures:
- Incidence of Grade 2 and 3 HFS as graded by Roche Criteria [ Time Frame: Maximum of 6 months of therapy ] [ Designated as safety issue: Yes ]
- Time to first HFS event
- Requirements for capecitabine dose reduction/interruption due to HFS
- Digital Photos will be taken of the hands and feet at specific intervals
- Serum Pharmacokinetic Levels of Uracil will be drawn [ Time Frame: Maximum of 6 months of therapy ] [ Designated as safety issue: Yes ]Pharmacokinetic levels will be drawn at specific intervals
Secondary Outcome Measures:
- Anti-Tumor efficacy of Capecitabine [ Time Frame: Maximum of 6 months of therapy ] [ Designated as safety issue: Yes ]RECIST - Radiologic Criteria for subjects with measurable disease
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo Lotion |
Drug: Ointment
Twice daily lotion to prevent HFS
|
| Experimental: 0.1% Uracil |
Drug: 0.1% Uracil Ointment
Twice daily lotion to prevent HFS
|
Detailed Description:
Capecitabine is used in the treatment of human breast cancer among other human cancers. Following absorption, capecitabine is converted enzymatically to 5-fluorouracil (5-FU). The administration of capecitabine or 5-FU can cause a cutaneous toxicity known as hand-foot syndrome (HFS) or palmar-plantar erythrodysesthesia (PPE). HFS is progressive with dose and duration of exposure to 5-FU or capecitabine. HFS is characterized by progressive redness and cracking of hands and feet. Currently, there are no approved therapies for HFS.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Females, at least 18 years old
- Histologically or cytologically confirmed metastatic breast cancer
- You also cannot have any ulcerations or open wounds on palms of hands or soles of feet
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C)prior to entering the study or if you have not recovered to Grade 1 or better (except for alopecia)from adverse events due to agents administered more than 2 weeks earlier.
- Use vitamin 6, chronic use of Cox-2 inhibitors, use full-dose anti- coagulants or use nicotine patches.
The above is not a complete list of eligibility criteria. Please see your study doctor for more information.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100463
Contacts
| Contact: Michael R Myers, BA, MA | 410-889-2221 | mmyers@rpsweb.com |
| Contact: Joi Stone | 866-877-7376 ext 3710 | jstone@rpsweb.com |
Locations
| United States, Alabama | |
| Bruno Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35205 | |
| Contact: Brittany White 205-939-7880 Brittany.White@bhoallc.com | |
| Principal Investigator: James Cantrell, MD | |
| United States, California | |
| Comprehensive Cancer Center | Not yet recruiting |
| Palm Springs, California, United States, 92262 | |
| Contact: Susan Sagle, RN 760-416-4734 ssagle@aptiumoncology.com | |
| Principal Investigator: Cynthia Leichman, MD | |
| United States, Indiana | |
| Research Institute of Deaconess Clinic | Recruiting |
| Evansville, Indiana, United States, 47713 | |
| Contact: Lou Ann Shoaff 812-426-9390 louann_shoaff@deaconess.com | |
| Principal Investigator: Maqbool Ahmed, MD | |
| Cancer Care Center | Recruiting |
| New Albany, Indiana, United States, 47150 | |
| Contact: Denette Grider, RN 812-945-4000 ext 113 | |
| Principal Investigator: Naveed Chowhan, MD | |
| United States, Kansas | |
| Kansas City Cancer Centers | Recruiting |
| Overland Park, Kansas, United States, 66210 | |
| Contact: Cathy Wight 913-541-4672 cathy.wight@usoncology.com | |
| Principal Investigator: Kelly Pendergrass, MD | |
| United States, Ohio | |
| Signal Point Clinical Research Center | Recruiting |
| Middleton, Ohio, United States, 45042 | |
| Contact: Heather Snowden 513-423-0504 hasnowden@swohio.twcbc.com | |
| Principal Investigator: Nandagopal S Vrindavanam, MD | |
Sponsors and Collaborators
Cahaba Pharmaceuticals
Investigators
| Principal Investigator: | James Cantrell, MD | Birmingham Hematology/Oncology Associates |
More Information
No publications provided
| Responsible Party: | James Cantrell, MD, Birmingham Hematology/Oncology Associates LLC |
| ClinicalTrials.gov Identifier: | NCT01100463 History of Changes |
| Other Study ID Numbers: | OIC-1UO-C001 |
| Study First Received: | April 6, 2010 |
| Last Updated: | April 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cahaba Pharmaceuticals:
|
HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Capecitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013