Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00350792
• Collaborator: (none)
• Enrollment: 62
• Locations: 7
• Arm: 1
• Duration (Months): 39
• Patients Per Site: 8.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: pemetrexed; Drug: carboplatin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pemetrexed + Carboplatin Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.	Drug: pemetrexed; 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles; Other Names: LY231514 Alimta ; Drug: carboplatin; Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response) [baseline to measured objective tumor response (up to six 21-day cycles)]

   Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.

Secondary Outcome Measures

1. Time to Treatment Failure [baseline to stopping treatment (up to six 21-day cycles)]

   Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.

2. Overall Survival [baseline to date of death from any cause (up to 14.5 months)]

   Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

3. Estimated Probability of One Year Progression-free Survival [baseline to measured progressive disease or death, 1 year]

   Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.

Other Outcome Measures

1. Time to Treatment Failure [baseline to stopping treatment (up to six 21-day cycles)]

   Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV

• No previous chemotherapy for lung cancer

• Men and women > or = 70 years

• At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors [RECIST]criteria)

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1

Exclusion Criteria:

• Treatment within the last 30 days with a drug that has not received regulatory approval

• Serious systemic disorders

• Inability to discontinue administration of aspirin or anti-inflammatory non steroid

• Concurrent administration of any other antitumor therapy

• Brain metastasis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bobigny		France	93009
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brest		France	29609
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Caen		France	14076
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Le Mans		France	72000
5	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lille		France	59000
6	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nantes		France	44202
7	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Vandoeuvre Les Nancy		France	54511

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00350792
• Other Study ID Numbers: 9941; H3E-FP-S099
• First Posted: Jul 11, 2006
• Last Update Posted: Oct 13, 2010
• Last Verified: Oct 1, 2010

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carboplatin; Pemetrexed

Study Results

Participant Flow

Arm/Group Title	Pemetrexed + Carboplatin
Arm/Group Description	Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
Period Title: Overall Study
STARTED	62
COMPLETED	29
NOT COMPLETED	33

Baseline Characteristics

Arm/Group Title	Pemetrexed + Carboplatin
Arm/Group Description	Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
Overall Participants	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.5 (3.6)
Sex: Female, Male (Count of Participants)
Female	11 17.7%
Male	51 82.3%
Region of Enrollment (participants) [Number]
France	62 100%
Disease Stage (participants) [Number]
Stage IIIB	13 21%
Stage IV	49 79%
Eastern Cooperative Oncology Group (ECOG) Performance Status (participants) [Number]
0 - Fully Active	10 16.1%
1 - Ambulatory, Restricted Strenuous Activity	52 83.9%
Pathological Diagnosis (participants) [Number]
Large Cell Lung Cancer	5 8.1%
Adenocarcinoma of Lung	32 51.6%
Squamous Cell Carcinoma of Lung	21 33.9%
Other: Carcinoma-Infiltrant Indifferencie	1 1.6%
Other: Carcinoma	1 1.6%
Other: Indifferencied Non-Small Cell Lung Cancer	1 1.6%
Other: Undifferentiated	1 1.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
Description	Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
Time Frame	baseline to measured objective tumor response (up to six 21-day cycles)

Outcome Measure Data

Analysis Population Description

Patients qualified for tumor response analysis: treated patients, with measurable advanced non-small cell lung cancer (NSCLC) disease and at least one tumor assessment after the patient received at least a first cycle of chemotherapy (unless early progression occurs, including early clinical progressions confirmed by the assessment committee).

Arm/Group Title	Pemetrexed + Carboplatin
Arm/Group Description	Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
Measure Participants	49
Number [percentage of participants]	28.6 46.1%

2. Other Pre-specified Outcome

Title	Time to Treatment Failure
Description	Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Time Frame	baseline to stopping treatment (up to six 21-day cycles)

Outcome Measure Data

Analysis Population Description

All treated patients. 29 patients were censored.

Arm/Group Title	Pemetrexed + Carboplatin
Arm/Group Description	Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
Measure Participants	62
Mean (Standard Error) [weeks]	12.95 (0.74)

3. Secondary Outcome

Title	Time to Treatment Failure
Description	Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Time Frame	baseline to stopping treatment (up to six 21-day cycles)

Outcome Measure Data

Analysis Population Description

All treated patients. 29 patients were censored.

Arm/Group Title	Pemetrexed + Carboplatin
Arm/Group Description	Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
Measure Participants	62
Median (95% Confidence Interval) [weeks]	16.0

4. Secondary Outcome

Title	Overall Survival
Description	Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time Frame	baseline to date of death from any cause (up to 14.5 months)

Outcome Measure Data

Analysis Population Description

Twenty patients were censored as they were still alive at the time of the data cut-off.

Arm/Group Title	Pemetrexed + Carboplatin
Arm/Group Description	Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
Measure Participants	62
Median (95% Confidence Interval) [months]	10.4

5. Secondary Outcome

Title	Estimated Probability of One Year Progression-free Survival
Description	Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.
Time Frame	baseline to measured progressive disease or death, 1 year

Outcome Measure Data

Analysis Population Description

Six patients were censored as they had not experienced a qualifying event (death or first disease progression) at the time of data cut-off.

Arm/Group Title	Pemetrexed + Carboplatin
Arm/Group Description	Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
Measure Participants	62
Median (95% Confidence Interval) [percentage of patients]	13.1

Adverse Events

Arm/Group Title	Pemetrexed + Carboplatin
Arm/Group Description	Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
All Cause Mortality
	Pemetrexed + Carboplatin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pemetrexed + Carboplatin
	Affected / at Risk (%)	# Events
Total	26/62 (41.9%)
Blood and lymphatic system disorders
Anaemia	4/62 (6.5%)	5
Bone marrow failure	1/62 (1.6%)	1
Febrile bone marrow aplasia	1/62 (1.6%)	2
Febrile neutropenia	1/62 (1.6%)	1
Leukopenia	1/62 (1.6%)	2
Neutropenia	3/62 (4.8%)	4
Pancytopenia	1/62 (1.6%)	1
Thrombocytopenia	4/62 (6.5%)	6
Cardiac disorders
Arrhythmia	1/62 (1.6%)	1
Arrhythmia supraventricular	1/62 (1.6%)	1
Atrial fibrillation	1/62 (1.6%)	1
Tachycardia	1/62 (1.6%)	1
Gastrointestinal disorders
Abdominal pain	1/62 (1.6%)	1
Colitis ischaemic	1/62 (1.6%)	1
Diarrhoea	3/62 (4.8%)	3
Nausea	1/62 (1.6%)	1
Sigmoiditis	1/62 (1.6%)	1
Vomiting	1/62 (1.6%)	1
General disorders
Fatigue	1/62 (1.6%)	1
General physical health deterioration	4/62 (6.5%)	4
Mucosal inflammation	1/62 (1.6%)	1
Immune system disorders
Drug hypersensitivity	1/62 (1.6%)	1
Infections and infestations
Catheter related infection	1/62 (1.6%)	1
Pneumonia	1/62 (1.6%)	1
Sepsis	2/62 (3.2%)	2
Septic shock	1/62 (1.6%)	1
Investigations
White blood cell count decreased	1/62 (1.6%)	1
Metabolism and nutrition disorders
Anorexia	1/62 (1.6%)	1
Dehydration	1/62 (1.6%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/62 (1.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis	1/62 (1.6%)	1
Psychiatric disorders
Anxiety	1/62 (1.6%)	1
Confusional state	1/62 (1.6%)	1
Depression	1/62 (1.6%)	1
Renal and urinary disorders
Haematuria	1/62 (1.6%)	1
Renal failure	1/62 (1.6%)	1
Renal failure acute	1/62 (1.6%)	1
Urinary retention	1/62 (1.6%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/62 (1.6%)	1
Acute respiratory failure	1/62 (1.6%)	1
Dyspnoea	6/62 (9.7%)	6
Haemoptysis	1/62 (1.6%)	1
Pulmonary congestion	1/62 (1.6%)	1
Pulmonary oedema	1/62 (1.6%)	1
Respiratory distress	1/62 (1.6%)	1
Skin and subcutaneous tissue disorders
Toxic skin eruption	1/62 (1.6%)	1
Vascular disorders
Hypotension	1/62 (1.6%)	1
Other (Not Including Serious) Adverse Events
	Pemetrexed + Carboplatin
	Affected / at Risk (%)	# Events
Total	61/62 (98.4%)
Blood and lymphatic system disorders
Anaemia	35/62 (56.5%)	43
Leukopenia	12/62 (19.4%)	23
Neutropenia	44/62 (71%)	115
Thrombocytopenia	29/62 (46.8%)	68
Gastrointestinal disorders
Constipation	21/62 (33.9%)	26
Diarrhoea	12/62 (19.4%)	14
Nausea	21/62 (33.9%)	32
Stomatitis	4/62 (6.5%)	4
Vomiting	14/62 (22.6%)	17
General disorders
Asthenia	42/62 (67.7%)	63
Chest pain	7/62 (11.3%)	7
Oedema peripheral	5/62 (8.1%)	5
Pyrexia	6/62 (9.7%)	12
Investigations
Weight decreased	23/62 (37.1%)	24
Weight increased	4/62 (6.5%)	4
White blood cell count decreased	4/62 (6.5%)	5
Metabolism and nutrition disorders
Anorexia	25/62 (40.3%)	30
Psychiatric disorders
Insomnia	7/62 (11.3%)	7
Respiratory, thoracic and mediastinal disorders
Cough	10/62 (16.1%)	10
Dyspnoea	11/62 (17.7%)	11
Epistaxis	6/62 (9.7%)	7
Haemoptysis	4/62 (6.5%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.