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3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Tithi Biswas
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights

Study Summary

This trial is testing methoxyamine given with other drugs and radiation to treat non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Large Cell Carcinoma
  • Lung Cancer
  • Lung Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of toxicity of the combination therapy
Maximum tolerated dose (MTD) of methoxyamine in combination with pemetrexed disodium, cisplatin, and radiation therapy
Secondary outcome measures
Change in lab correlative expression levels (including UNG, TS, ERCC1, Ki-67 and TopoII-alpha)
Disease-free survival
Progression-free survival (PFS)
+1 more

Side effects data

From 2021 Phase 3 trial • 5377 Patients • NCT00103285
81%
Neutrophil count decreased
61%
Febrile neutropenia
57%
Infections and infestations - Other, specify
46%
White blood cell decreased
43%
Alanine aminotransferase increased
36%
Anemia
32%
Platelet count decreased
23%
Aspartate aminotransferase increased
13%
Anaphylaxis
12%
Hypokalemia
11%
Diarrhea
9%
Dehydration
9%
Anorexia
9%
Lymphocyte count decreased
9%
Mucositis oral
9%
Peripheral motor neuropathy
8%
Fever
7%
Hyperglycemia
7%
Lung infection
7%
Vomiting
7%
Hyponatremia
6%
Lipase increased
6%
Enterocolitis infectious
6%
Upper respiratory infection
6%
Blood bilirubin increased
6%
Abdominal pain
6%
Otitis media
5%
Hypocalcemia
5%
Hypoalbuminemia
5%
Catheter related infection
5%
Fibrinogen decreased
5%
GGT increased
4%
Hypoglycemia
4%
Peripheral sensory neuropathy
4%
Hypoxia
3%
Sinusitis
3%
Skin infection
3%
Urinary tract infection
3%
Seizure
2%
Pain in extremity
2%
Back pain
2%
Headache
2%
Oral pain
2%
Pleural effusion
2%
Nausea
2%
Abdominal infection
2%
Pharyngitis
2%
Serum amylase increased
2%
Pancreatitis
2%
Middle ear inflammation
2%
Constipation
2%
Dysphagia
2%
Esophagitis
2%
Bladder infection
2%
Hypertension
2%
Hyperkalemia
2%
Hypophosphatemia
2%
Pneumonitis
2%
Rash maculo-papular
2%
Weight loss
1%
General disorders and administration site conditions - Other, specify
1%
Bronchial infection
1%
Small intestine infection
1%
Hypermagnesemia
1%
Depressed level of consciousness
1%
Urinary tract pain
1%
Neuralgia
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Skin ulceration
1%
Bronchospasm
1%
Gum infection
1%
Lip infection
1%
Pain
1%
Otitis externa
1%
Activated partial thromboplastin time prolonged
1%
Hypertriglyceridemia
1%
Bone pain
1%
Gastrointestinal disorders - Other, specify
1%
Ileus
1%
Agitation
1%
Depression
1%
Typhlitis
1%
Acute kidney injury
1%
Fatigue
1%
Cholecystitis
1%
Gallbladder obstruction
1%
Immune system disorders - Other, specify
1%
Dyspnea
1%
Weight gain
1%
Urticaria
1%
Thromboembolic event
1%
Muscle weakness lower limb
1%
Anxiety
1%
Personality change
1%
Urinary retention
1%
Aspiration
1%
Cough
1%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy
Group 1-SR-low ALL, Arm II-combination Chemotherapy
Group 2-SR-avg ALL, Arm I-combination Chemotherapy
Group 2-SR-avg ALL, Arm II-combination Chemotherapy
Group 2-SR-avg ALL, Arm III-combination Chemotherapy
Group 3-SR-high ALL, Combination Chemotherapy
Group 0 Induction Therapy
Group 1-SR-low ALL, Arm I-combination Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pemetrexed, methoxyamine, cisplatin, RT)Experimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Cisplatin
2013
Completed Phase 3
~1940
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Methoxyamine
2007
Completed Phase 1
~90
Methoxyamine Hydrochloride
2015
Completed Phase 1
~20
Pemetrexed Disodium
2015
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,444 Total Patients Enrolled
Tithi BiswasPrincipal InvestigatorCase Western Reserve University
1 Previous Clinical Trials
42 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer
2015. "Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02535325.
~2 spots leftby Apr 2025
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