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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02535325
Other study ID # NCI-2015-01408
Secondary ID NCI-2015-01408CA
Status Completed
Phase Phase 1
First received
Last updated
Start date September 30, 2015
Est. completion date June 14, 2022

Study information

Verified date June 2022
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms

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Intervention

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Locations

Country Name City State
United States Case Western Reserve University Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) of methoxyamine in combination with pemetrexed disodium, cisplatin, and radiation therapy 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. 21 days
Primary Incidence of toxicity of the combination therapy Will be graded according to NCI CTCAE version 5.0. Toxicity data will be tabulated. Up to 6 months
Secondary Progression-free survival (PFS) 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. At 6 months
Secondary Disease-free survival 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. Up to 6 months
Secondary Response rate (clinical/tumor response) 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. Up to 6 months
Secondary Change in lab correlative expression levels (including UNG, TS, ERCC1, Ki-67 and TopoII-alpha) 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. Baseline to up to 6 months
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