Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin

NCT00831571 | Completed DMC

• 2 other identifiers: 08-140SANOFI OX-07-008
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will examine how often hypersensitivity, or allergic reactions, occur in patients receiving the chemotherapy medication oxaliplatin. Hypersensitivity reactions can vary from a transient skin rash and fever to more severe symptoms such as shortness of breath, chest tightness, and a more severe allergic reaction that can affect blood pressure called anaphylaxis. We will be examining how often hypersensitivity reactions occur and how severe the reactions are when they occur. We will also examine whether there are factors that place people at risk for developing hypersensitivity reactions to oxaliplatin. In an optional portion to this study, we will examine whether allergy skin testing can predict whether someone will develop a hypersensitivity reaction. Participants who develop a moderate to severe allergic reaction to oxaliplatin will be invited to participate in an additional portion of the study examining a desensitization process. This part of the study will examine whether a desensitization process can prevent future hypersensitivity reactions to oxaliplatin in patients who previously developed moderate to severe hypersensitivity reactions and allow therapy with oxaliplatin to continue.

Conditions

Colorectal Cancer; Esophageal Cancer; Gastric Cancer; Small Bowel Cancer; Pancreatic Cancer

Keywords

oxaliplatin; hypersensitivity

Outcome Measures

Primary Outcomes (1)

• To determine prospectively the incidence and severity of hypersensitivity reactions to oxaliplatin among patients beginning treatment with oxaliplatin during a two-year observation period.

  2 years

Secondary Outcomes (3)

• To determine the relationship between cumulative dose of oxaliplatin and duration of therapy and development of hypersensitivity reactions.

  2 years

• To determine the ability of oxaliplatin skin testing to identify patients at risk for developing hypersensitivity reactions.

  2 years

• To determine the safety and efficacy of a rapid desensitization protocol to allow responding patients with moderate to severe hypersensitivity reactions to oxaliplatin to continue therapy with the drug.

  2 years

Study Arms (2)

All Participants

Patients receiving Oxaliplatin

Desensitization

Patients that have experienced a moderate to severe hypersensitivity reaction to oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at Dana-Farber Cancer Institute with the chemotherapy drug oxaliplatin.

You may qualify if:

• years of age or older
• Histologically or cytologically confirmed colorectal cancer, esophageal cancer, gastric cancer, small bowel cancer, hepatobiliary cancer and pancreatic cancer
• Patients must be eligible for treatment with oxaliplatin
• ECOG Performance Status of 2 or less
• Adequate bone marrow, renal and hepatic function as outlined in the protocol
• Patients must have recovered from both the acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
• Patients may participate in monitoring for hypersensitivity and skin testing if they are receiving oxaliplatin as part of another clinical trial and allowed by that trial. Patients cannot receive oxaliplatin through the desensitization protocol if they are part of another clinical trial.

You may not qualify if:

• Prior treatment with oxaliplatin
• Active infection or with a fever of 101.3 or higher within 3 days of the first scheduled days of protocol treatment
• Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for greater than 3 weeks are eligible.
• Patients with known hypersensitivity to any of the components of oxaliplatin or chemotherapeutic agent used in combination with oxaliplatin
• Patients who have received radiotherapy to more than 25% of their bone marrow; or patients who received any radiotherapy within 4 weeks of study entry
• Peripheral neuropathy of grade 2 or higher
• Patients who are pregnant or lactating
• Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patient's ability to sign informed consent, cooperate and participate in teh study, or interfere with the interpretation of the results.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Sanofi: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Hypersensitivity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Immune System Diseases

Study Officials

• Jennifer A. Chan, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 29, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

US (1)