Neoplasms

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CYCLES 1-2: Patients receive pemetrexed disodium IV over 10 minutes and methoxyamine hydrochloride PO day 1; and cisplatin IV over 0.5-24 hours on day 3. Patients also undergo 3-D conformal RT or IMRT QD 5 days a week (3 days of week 1 and 4 days of week 4) for 30 fractions total.

CYCLES 3-4: Beginning at least 10 days after RT completion, patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 0.5-24 hours on day 1.

Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

3-Dimensional Conformal Radiation Therapy

Intensity-Modulated Radiation Therapy

Methoxyamine

Methoxyamine Hydrochloride

Pemetrexed Disodium

Tithi Biswas

This phase I trial studies the side effects and best dose of methoxyamine when given together with pemetrexed disodium, cisplatin, and radiation therapy in treating patients with stage IIIA-IV non-small cell lung cancer. Drugs used in chemotherapy, such as methoxyamine hydrochloride, pemetrexed disodium, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving methoxyamine hydrochloride together with pemetrexed disodium, cisplatin, and radiation therapy may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of methoxyamine (TRC102) in combination with pemetrexed disodium (pemetrexed)-cisplatin and thoracic radiotherapy.

SECONDARY OBJECTIVES:

I. To (descriptively) assess the toxicity profile of methoxyamine (TRC102) in combination with pemetrexed-cisplatin and thoracic radiotherapy.

II. To (descriptively) assess the short-term progression-free survival at 6 months (PFS6) in the patients treated on this protocol.

III. To observe and record anti-tumor activity.

OUTLINE: This is a dose-escalation study of methoxyamine hydrochloride.

CYCLES 1-2: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes and methoxyamine hydrochloride orally (PO) day 1; and cisplatin IV over 0.5-24 hours on day 3. Patients also undergo 3-dimensional (3-D) conformal radiation therapy (RT) or intensity-modulated radiation therapy (IMRT) once daily (QD) 5 days a week (3 days of week 1 and 4 days of week 4) for 30 fractions total.

CYCLES 3-4: Beginning at least 10 days after RT completion, patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 0.5-24 hours on day 1.

Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 weeks and then every 3 months for 6 months.

Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer

A Phase I Study of Methoxyamine Combined With Chemo-Radiation for Locally Advanced Non-Squamous Non-Small Cell Lung Cancer

Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. MTD is defined as the highest dose level in which 0/6 or 1/6 patients suffer dose-limiting toxicity.

Will be graded according to NCI CTCAE version 5.0. Toxicity data will be tabulated.

PFS is analyzed using the Kaplan-Meier method. Factors, such as age, gender, baseline histology and lab correlates including uracil deoxyribonucleic acid (DNA) N-glycosylase (UNG), thymidylate synthase (TS), excision repair cross-complementation group 1 (ERCC1), Ki-67 and Topoisomerase II-alpha (TopoII-alpha) that predict survival will be identified by Cox model or extended Cox model.

Disease-free survival is analyzed using the Kaplan-Meier method. Factors, such as age, gender, baseline histology and lab correlates including UNG, TS, ERCC1, Ki-67 and TopoII-alpha that predict survival will be identified by Cox model or extended Cox model.

The true response rate of the combination therapy for this patient population will be estimated based on the number of responses using a binomial distribution and its confidence intervals will be estimated using Wilson's method. The factors that predict the response will be identified by logistic regression.

The change of lab correlatives measured at baseline and post-treatment will be compared by paired T-test for interval scale measure and McNemar test for nominal measure.

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer	NCT02535325	Locally Advance... Stage III Lung ... Stage III Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIA Lung... Stage IIIA Lung... Stage IIIB Lung... Stage IIIB Lung... Stage IIIB Lung... Stage IV Lung A... Stage IV Lung L... Stage IV Lung N...	3-Dimensional C... Cisplatin Intensity-Modul... Methoxyamine Methoxyamine Hy... Pemetrexed Pemetrexed Diso...	18 Years -	National Cancer Institute (NCI)
Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer	NCT02535325	Locally Advance... Stage III Lung ... Stage III Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIA Lung... Stage IIIA Lung... Stage IIIB Lung... Stage IIIB Lung... Stage IIIB Lung... Stage IV Lung A... Stage IV Lung L... Stage IV Lung N...	3-Dimensional C... Cisplatin Intensity-Modul... Methoxyamine Methoxyamine Hy... Pemetrexed Pemetrexed Diso...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for stage iiia lung large cell carcinoma ajcc v7