NCT02535325

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma
• Stage III Lung Adenocarcinoma AJCC v7
• Stage III Lung Large Cell Carcinoma AJCC v7
• Stage III Lung Non-Small Cell Cancer AJCC v7
• Stage IIIA Lung Adenocarcinoma AJCC v7
• Stage IIIA Lung Large Cell Carcinoma AJCC v7
• Stage IIIA Lung Non-Small Cell Cancer AJCC v7
• Stage IIIB Lung Adenocarcinoma AJCC v7
• Stage IIIB Lung Large Cell Carcinoma AJCC v7
• Stage IIIB Lung Non-Small Cell Cancer AJCC v7
• Stage IV Lung Adenocarcinoma AJCC v7
• Stage IV Lung Large Cell Carcinoma AJCC v7
• Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions

Type	Name	Description
RADIATION	3-Dimensional Conformal Radiation Therapy	Undergo 3-D conformal RT
DRUG	Cisplatin	Given IV
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT
DRUG	Methoxyamine	Given PO
DRUG	Methoxyamine Hydrochloride	Given PO
DRUG	Pemetrexed	Given IV
DRUG	Pemetrexed Disodium	Given IV

Timeline

• Start date: 2015-09-30
• Primary completion: 2020-02-27
• Completion: 2022-06-14
• First posted: 2015-08-28
• Last updated: 2022-06-30

Locations

1 site across 1 country: United States