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21CTP.HN01 Site Feasibility Questionnaire

21CTP.HN01 "CAPT-HN"

21CTP.HN01, CAPT-HN: "A Phase II Study Of Combined Amivantamab, Carboplatin And Paclitaxel In Unresectable Locally Recurrent Or Metastatic Head And Neck Cancer"
Your site is identified as a SWOG member, and we invite your participation in the SWOG Clinical Trial Partnership (CTP).
SWOG CTP is an independent, limited liability corporation with its own leadership, processes, and funding agreements. But the missions of SWOG and SWOG CTP are the same - to significantly improve lives through cancer clinical trials and translational research.
This clinical trial aims to find out if adding amivantamab hyaluronidase to the usual chemotherapy treatment can improve the usual treatment for advanced head and neck cancers.
The following questionnaire aims to collect essential information about potential clinical trial sites to evaluate their suitability for the upcoming study. Please complete the summary by providing accurate and detailed responses to each section. Your input will greatly assist in assessing the feasibility of these sites and ensuring the successful execution of the study. Thank you for your participation in this site survey.
Schema:
Key Eligibility:

Inclusion criteria

1. Histologically documented squamous cell head and neck carcinoma that:
a. was metastatic at diagnosis OR
b. persisted, metastasized, or recurred after definitive treatment OR
c. recurred locally and patient has contraindication to surgery or has refused surgery or radiation

2. Both HPV positive and negative are eligible

3. Cancers may originate from the wet lip, oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, epiglottis, or nasal cavity/paranasal sinuses

4. Presence of measurable disease by CT or MRI within 28 days of registration

5. Must have received prior treatment for head and neck cancer with a systemic PD-(L)1 or PD-1 inhibitor (in any setting)

6. Up to two prior systemic therapy regimens for recurrent and/or metastatic disease

7. ECOG performance status of 0-1

8. Age 18 years or older

9. Complete medical history and physical exam, with adequate organ and bone marrow function, with 28 days of registration

10. Must have calculated creatinine clearance >=45 mL/min using Cockcroft-Gault formula

11. If HIV-positive, must be on antiretroviral therapy with undetectable viral load on most recent test, within 6 months of registration

12. If history of hepatitis C, must have been treated and cured

13. If history of chronic hepatitis B, must have undetectable viral load on suppressive therapy on most recent test, within 6 months of registration

14. If of reproductive potential, must agree to use effective contraceptive method

Exclusion Criteria

1. Prior anti-cancer therapy within 14 days of registration

2. Received platinum or taxane agent as part of prior treatment for recurrent or metastatic disease

3. Prior treatment with cetuximab or another EGFR inhibitor in the locally recurrent advanced unresectable or metastatic setting

4. Hypersensitivity and/or contraindication to carboplatin or paclitaxel

5. Active cardiovascular disease

6. Congestive heart failure within 6 months of registration

7. An uncontrolled illness

8. Major surgery or significant traumatic injury within 28 days of registration

9. Surgery planned during time of expected study participation

10. Other clinically active or infectious liver diseases

11. Concurrent malignancy whose natural history or treatment has potential to interfere with safety or efficacy assessment of the investigational regimen

12. Pregnant or nursing