Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
