Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02124707 |
|
Recruitment Status :
Completed
First Posted : April 28, 2014
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
|
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a non-randomized, open-label phase II trial of 38 patients with recurrent or metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating physician at their discretion may continue to treat with weekly cetuximab as maintenance until disease progression. The study is designed to evaluate whether this regimen improves median overall survival (OS) as compared to an historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource intensive. Our study regimen has been used extensively for induction therapy and off-protocol in palliative care, but treatment outcomes have yet to be defined by a clinical trial.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Cancer Squamous Cell Carcinoma of the Head and Neck | Drug: Cetuximab Drug: Paclitaxel Drug: Carboplatin | Phase 2 |
Because of their high response rates and low toxicity, the taxane, carboplatin, cetuximab regimens have frequently been adapted for use in the palliative setting. At UNC, we have observed high rates of response, leading to symptomatic benefit and low toxicity. Further, the regimen de-medicalizes the patient's life in several important ways. First, unlike with the EXTREME regimen, no PORT or 4 day infusion is required. Second, the regimen gives only six weeks of cytotoxic therapy. Finally, in our experience there is a low rate of severe toxicity and this, coupled with the high rate of response, may improve quality of life. We are not aware of any presented or published results on the use of this combination in palliative therapy; with the adoption of this regimen in clinical practice, documentation of its benefit via conduct of a clinical trial is needed.
We propose a study designed to detect an improvement in median OS versus a historical control. The control arm from the EXTREME trial achieved a median OS of 7.4 months. We hypothesize that a less toxic and more effective 3-drug regimen will result in improved median OS compared with the control arm from EXTREME (median 7.4 months). The toxicity associated with EXTREME is primarily attributable to the cisplatin and 5FU cytotoxic backbone as its toxicity has been consistent in multiple studies of both palliative therapy and induction therapy. If a 4-month improvement in OS is achieved with acceptable toxicity, we will consider this regimen worth of further study.
Secondary objectives will include characterizing changes in quality of life (QoL), symptoms and toxicities. Patients will be encouraged to co-enroll into the UNCseq protocol for further exploration of associations between genetic changes and clinical outcomes.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | LCCC 1330 - A Phase II Study of Weekly Carboplatin, Paclitaxel and Cetuximab for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
| Actual Study Start Date : | June 16, 2014 |
| Actual Primary Completion Date : | October 1, 2019 |
| Actual Study Completion Date : | October 1, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Head and neck squamous cell carcinoma
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Carboplatin, Paclitaxel and Cetuximab
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
|
Drug: Cetuximab
400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
Other Name: Erbitux Drug: Paclitaxel 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Other Name: Taxol Drug: Carboplatin AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks.
Other Name: Paraplatin |
Primary Outcome Measures :
- Median Overall Survival [ Time Frame: 36 months ]Overall survival after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab is defined as the time from D1 of treatment under this protocol until death as a result of any cause.
Secondary Outcome Measures :
- Median Progression Free Survival [ Time Frame: 36 months ]Progression events will be defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Progression free survival after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab is defined as the time from Day 1 of treatment until progression or death as a result of any cause.
- Overall Response Rate by Participants [ Time Frame: 6 weeks ]Number of complete response (CR) and partial response (PR) after study treatment with weekly carboplatin, paclitaxel, and cetuximab for 6 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: CR is defined as disappearance of all target lesions; and PR as >=30% decrease in the sum of the longest diameter of target lesions
- Incidence of Adverse Events [ Time Frame: 18 weeks ]Grade 3 and 4 toxicities associated with this combined chemotherapy regimen as assessed by clinician assessment using the NCI Common Terminology Criteria for Adverse Events,a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of daily living (ADL). Grade 4 Life-threatening consequences; urgent intervention indicated. Describe patient reported symptoms associated with this regimen.
- Head and Neck Quality of Life Assessments [ Time Frame: Baseline, End of treatment (EOT), First follow-up visit (8-12 weeks after EOT) ]Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) questionnaire. The FACT-HN is the FACT-General (FACT-G) and a head and neck cancer specific, 12 item subscale given at baseline, at end of treatment, and at first follow-up visit. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4, with all subscales summed to give a total score with a range of 0-148 Higher scores represent better QOL.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Histologically or cytologically confirmed recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN). All primary sites are eligible excluding WHO type III or EBV nasopharyngeal (WHO type I and WHO type II allowed as long as they are EBV negative)
- ECOG performance status 0-1
- Adequate organ and marrow function as defined below. Laboratory tests should be completed within 14 days prior to registration: ANC greater than or equal to 1,500/mm3, Platelets greater than or equal to 100,000/mm3, HgB greater than 9g/dL (acceptable to reach this by transfusion), Total bilirubin less than or equal to 1.5mg/dL, Albumin greater than 2.5 g/dL, AST(SGOT)/ALT(SGPT) less than or equal to 2.5X institutional upper limit of normal, alkaline phosphatase less than or equal to 2.5 x upper limit of normal, GFR greater than 30 mL/min (by standard Cockroft and Gault formula or measured via 24 hour urine collection)
- Women of childbearing potential (WOCBP) with negative serum or urine pregnancy test within 7 days of D1 of treatment
- WOCBP and men must agree to use adequate contraception prior to study entry and for duration of treatment under this protocol; adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care.
- Cancer must be considered incurable by the treating clinician
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
- History of prior cumulative exposure to > 300mg/m2 cisplatin, AUC of 18 of carboplatin, or their combined equivalent within one year prior to enrollment
- Surgery or radiation within the four weeks prior to D1 of treatment under this protocol
- Prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry
- Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion
- Pregnant or lactating female
Information from the National Library of Medicine
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): NCT02124707
Locations
| United States, North Carolina | |
| The University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Virginia | |
| Bon Secours Virginia Health System | |
| Midlothian, Virginia, United States, 23114 | |
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
| Principal Investigator: | Jared Weiss, MD | University of North Carolina, Chapel Hill |
Study Documents (Full-Text)
Documents provided by UNC Lineberger Comprehensive Cancer Center:
Documents provided by UNC Lineberger Comprehensive Cancer Center:
Study Protocol and Statistical Analysis Plan [PDF] October 9, 2014
Additional Information:
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02124707 |
| Other Study ID Numbers: |
LCCC 1330 |
| First Posted: | April 28, 2014 Key Record Dates |
| Results First Posted: | August 12, 2020 |
| Last Update Posted: | August 12, 2020 |
| Last Verified: | August 2020 |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
Head and neck cancer Squamous cell carcinoma Metastatic Recurrent |
Phase II Carboplatin Paclitaxel Cetuximab |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Paclitaxel |
Carboplatin Cetuximab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |