Trial Outcomes & Findings for A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy (NCT NCT00447421)
NCT ID: NCT00447421
Last Updated: 2009-10-28
Results Overview
TERMINATED
PHASE1/PHASE2
9 participants
every cycle
2009-10-28
Participant Flow
This was a Phase 1/2 trial that was terminated during Phase 1 and never progressed to Phase 2. The number of patients enrolled is for the Phase 1 portion.
Participant milestones
| Measure |
Pemetrexed + Cisplatin
Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Pemetrexed + Cisplatin
Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Sponsor Decision
|
2
|
Baseline Characteristics
A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
Baseline characteristics by cohort
| Measure |
Pemetrexed + Cisplatin
n=9 Participants
Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
7 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: every cyclePopulation: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and it was too early to assess the recommended dose for Phase 2, or to estimate the maximum tolerated dose (MTD).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline to measured progressive diseasePopulation: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to measured responsePopulation: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and was stopped too early to assess best overall response.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to measured response timePopulation: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to measured progressive diseasePopulation: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time of response to progressive diseasePopulation: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to date of death from any causePopulation: This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.
Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.
Outcome measures
Outcome data not reported
Adverse Events
Pemetrexed + Cisplatin
Serious adverse events
| Measure |
Pemetrexed + Cisplatin
Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 2
|
|
Infections and infestations
Diverticulitis
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Lung infection
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
1/9 • Number of events 1
|
|
Vascular disorders
Femoral artery occlusion
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed + Cisplatin
Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
3/9 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
3/9 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal rigidity
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
4/9 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
3/9 • Number of events 3
|
|
Gastrointestinal disorders
Eructation
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Number of events 7
|
|
Gastrointestinal disorders
Oesophagitis
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
44.4%
4/9 • Number of events 4
|
|
Gastrointestinal disorders
Tongue coated
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Number of events 3
|
|
General disorders
Chest pain
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Fatigue
|
44.4%
4/9 • Number of events 4
|
|
General disorders
Injection site reaction
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Oedema
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Peripheral coldness
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Pyrexia
|
22.2%
2/9 • Number of events 2
|
|
Infections and infestations
Eye infection
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Lung infection
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Creatinine renal clearance decreased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Glomerular filtration rate decreased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Weight decreased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
55.6%
5/9 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid retention
|
55.6%
5/9 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
22.2%
2/9 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Cognitive disorder
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
22.2%
2/9 • Number of events 2
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Number of events 4
|
|
Nervous system disorders
Memory impairment
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
33.3%
3/9 • Number of events 3
|
|
Psychiatric disorders
Restlessness
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
22.2%
2/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
2/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
11.1%
1/9 • Number of events 1
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60