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Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Phase 2 trial testing cisplatin in Lung Cancer in 38 participants. Completed in 5 April 2017.
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 8 June 2005 |
| Primary completion | 29 April 2011 |
| Estimated completion | 5 April 2017 |
| Sites | 1 location across United States |
Roswell Park Cancer Institute
Adults 18 to 120, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor.
| Group | Value | 95% CI |
|---|---|---|
| Neoadjuvant Chemotherapy | 0 | 0 – 9.2 |
Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Please refer to the adverse event reporting for more detail.
| Group | Value | 95% CI |
|---|---|---|
| Neoadjuvant Chemotherapy | 2 | |
| Neoadjuvant Chemotherapy | 13 | |
| Neoadjuvant Chemotherapy | 19 | |
| Neoadjuvant Chemotherapy | 4 |
Overall survival was defined as time from date of treatment initiation until date of death due to any cause.
| Group | Value | 95% CI |
|---|---|---|
| Neoadjuvant Chemotherapy | 100.7 | 37 – 126 |
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions. Disease Free Survival was defined as time from date of treatment initiation until date of first documented progression or date of death from any cause, whichever came first.
| Group | Value | 95% CI |
|---|---|---|
| Neoadjuvant Chemotherapy | 34.5 | 14.7 – 126 |
Percent change of PET/SUV levels between baseline and post-chemotherapy.
| Group | Value | 95% CI |
|---|---|---|
| Neoadjuvant Chemotherapy | -36.1 | ± 40.6 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Neoadjuvant Chemotherapy |
|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Pericarditis | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Chest pain | General disorders | — |
| Pyrexia | General disorders | — |
| Cellulitis | Infections and infestations | — |
| Empyema | Infections and infestations | — |
| Infection | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Spinal fracture | Injury, poisoning and procedural complications | — |
| Blood creatine phosphokinase increased | Investigations | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Ischaemic stroke | Nervous system disorders | — |
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | — |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | — |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | — |
| Arterial thrombosis | Vascular disorders | — |
| Deep vein thrombosis | Vascular disorders | — |
| Thrombosis | Vascular disorders | — |
| Reaction | System | Neoadjuvant Chemotherapy |
|---|---|---|
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Tinnitus | Ear and labyrinth disorders | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Nasopharyngitis | Infections and infestations | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Insomnia | Psychiatric disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Headache | Nervous system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Asthenia | General disorders | — |
| Chest pain | General disorders | — |
| Influenza like illness | General disorders | — |
| Pain | General disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Hypoaesthesia | Nervous system disorders | — |
| Neuropathy peripheral | Nervous system disorders | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Tachycardia | Cardiac disorders | — |
Most-reported serious reactions: Dyspnoea, Anaemia, Pericarditis, Abdominal pain, Diarrhoea, Chest pain, Pyrexia, Cellulitis.
Data from ClinicalTrials.gov NCT00248495 adverse events section.
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before and after surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin before and after surgery works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00248495.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing