Zalutumumab in Patients With Non-curable Head and Neck Cancer
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| ClinicalTrials.gov Identifier: NCT00382031 |
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Recruitment Status :
Completed
First Posted : September 28, 2006
Results First Posted : October 15, 2013
Last Update Posted : October 15, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Cancer Squamous Cell Cancer | Drug: Zalutumumab Other: Control | Phase 3 |
This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.
Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.
Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 286 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy |
| Study Start Date : | November 2006 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | August 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: zalutumumab
Zalutumumab in combination with Best Supportive Care
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Drug: Zalutumumab
Individual dose titration weekly i.v doses
Other Name: Zalutumumab in combination with Best Supportive Care Other: Control Best Supportive Care
Other Name: Best Supportive Care |
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Control
Best Supportive Care
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Other: Control
Best Supportive Care
Other Name: Best Supportive Care |
- Overall Survival [ Time Frame: From randomization until death ]A patient's overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.
- Objective Tumor Response [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 41 months. ]Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR
- Duration of Response [ Time Frame: Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months. ]Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented.
- Progression Free Survival (PFS) [ Time Frame: From randomization until disease progression or death, assessed up to 41 months. ]PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and Females age ≥ 18 years
- Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
- Failure to at least one course of standard platinum-based chemotherapy
Exclusion Criteria:
- Three or more chemotherapy regimens other than platinum-based chemotherapy
- Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
- Past or current malignancy other than SCCHN, except for certain other cancer diseases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382031
Show 82 study locations
| Responsible Party: | Genmab |
| ClinicalTrials.gov Identifier: | NCT00382031 |
| Other Study ID Numbers: |
Hx-EGFr-202 |
| First Posted: | September 28, 2006 Key Record Dates |
| Results First Posted: | October 15, 2013 |
| Last Update Posted: | October 15, 2013 |
| Last Verified: | August 2013 |
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Head and Neck Neoplasms Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms by Site Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Carcinoma Zalutumumab Antibodies, Monoclonal Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |