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CMF regimen

cyclophosphamide

fluorouracil

methotrexate

Raymond A. Kempf, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide, methotrexate, and fluorouracil in treating patients with Merkel cell cancer.

OBJECTIVES: I. Investigate the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with unresectable Merkel cell carcinoma that is local-regional or metastatic. II. Determine the overall survival rate and objective response rate of these patients after treatment with cyclophosphamide, methotrexate, and fluorouracil.

OUTLINE: Patients are stratified according to local-regional disease versus metastatic disease. Patients receive cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicities. Patients are followed every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients (40 patients per stratum) will be accrued for this study.

S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer

A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)

National Cancer Institute (NCI)

SWOG Cancer Research Network

Neoplasms, Unknown Primary

Neoplasm Metastasis

Neoplastic Processes

Irinotecan

Topoisomerase I Inhibitors

irinotecan hydrochloride

Sunil Sharma, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced neuroendocrine tumors.

OBJECTIVES:

* Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors.
* Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 10-31 patients will be accrued for this study.

Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors

Memorial Sloan Kettering Cancer Center

Pembrolizumab

Lenvatinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.

20mg of Lenvatinib will be taken orally once daily

Lenvatinib Oral Product

200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.

Andrew Brohl, MD

Justin Martin

Nikhil Khushalani, MD

Zeynep Eroglu, MD

Ahmad Tarhini, MD

Vernon Sondak, MD

Youngchul Kim, PhD

Ken Tsai, PhD

This is a single arm trial of participants with Merkel cell carcinoma receiving a combination of lenvatinib plus pembrolizumab.

Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma

Neoadjuvant Lenvatinib Plus Pembrolizumab in Resectable Merkel Cell Carcinoma

Pathological Complete Response will be determined by pathologist examination of tissue after neoadjuvant treatment and resection

Progressive disease will be defined by the detection of any recurrent disease following complete surgical resection or by progression of disease that is not amenable to complete surgical resection prior to planned surgery.

Feasibility of treatment will be defined by the percentage of patients able to complete both neoadjuvant cycles of trial therapy and be able to complete surgical resection as planned.

Merck Sharp & Dohme LLC

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer	NCT00003549	Neuroendocrine ...	CMF regimen cyclophosphamid... fluorouracil methotrexate	18 Years -	SWOG Cancer Research Network
Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors	NCT00004922	Carcinoma of Un... Neuroendocrine ... Neuroendocrine ...	irinotecan hydr...	18 Years -	Memorial Sloan Kettering Cancer Center
Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors	NCT00004922	Carcinoma of Un... Neuroendocrine ... Neuroendocrine ...	irinotecan hydr...	18 Years -	Memorial Sloan Kettering Cancer Center
S9716: Combination Chemotherapy in Treating Patients With Merkel Cell Cancer	NCT00003549	Neuroendocrine ...	CMF regimen cyclophosphamid... fluorouracil methotrexate	18 Years -	SWOG Cancer Research Network
Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma	NCT04869137	Merkel Cell Car... Neuroendocrine ... Trabecular Carc...	Lenvatinib Oral... Pembrolizumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors	NCT00004922	Carcinoma of Un... Neuroendocrine ... Neuroendocrine ...	irinotecan hydr...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for neuroendocrine carcinoma of the skin