Trial Outcomes & Findings for S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer (NCT NCT00265785)

NCT ID: NCT00265785

Last Updated: 2012-11-01

Results Overview

Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 0 - 3 years
• Results posted on: 2012-11-01

Participant Flow

Participant milestones

Measure	Pemetrexed Pemetrexed Disodium 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Overall Study STARTED	27
Overall Study Eligible	26
Overall Study Eligible and Began Protocol Treatment	24
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Pemetrexed Pemetrexed Disodium 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	3
Overall Study Progression/Relapse	15
Overall Study Not protocol specified	2
Overall Study Ineligible	1
Overall Study Did not receive protocol treatment	2

Baseline Characteristics

S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Pemetrexed n=24 Participants Pemetrexed Disodium 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Age Continuous	68.2 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Histology Adenocarcinoma w/BAC features	18 participants n=5 Participants
Histology Bronchioloalveolar	6 participants n=5 Participants
Number of Metastatic Sites Single	12 participants n=5 Participants
Number of Metastatic Sites Multiple	7 participants n=5 Participants
Number of Metastatic Sites None	5 participants n=5 Participants
Stage IIIB	0 participants n=5 Participants
Stage IV	24 participants n=5 Participants
Prior EGFR-TKI Therapy No	19 participants n=5 Participants
Prior EGFR-TKI Therapy Yes	5 participants n=5 Participants
Prior Radiation Therapy Yes	3 participants n=5 Participants
Prior Radiation Therapy No	21 participants n=5 Participants
Prior Systemic Treatment Yes	10 participants n=5 Participants
Prior Systemic Treatment No	14 participants n=5 Participants
Prior Surgery Yes	11 participants n=5 Participants
Prior Surgery No	13 participants n=5 Participants
Zubbrod Performance Status 0	12 participants n=5 Participants
Zubbrod Performance Status 1	12 participants n=5 Participants
Smoking Status Current	5 participants n=5 Participants
Smoking Status Former	16 participants n=5 Participants
Smoking Status Never	3 participants n=5 Participants
Weight Loss Last 6 months < 5%	20 participants n=5 Participants
Weight Loss Last 6 months 5% to < 10%	3 participants n=5 Participants
Weight Loss Last 6 months 10% to 20%	1 participants n=5 Participants
Weight Loss Last 6 months > 20%	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 - 3 years

Population: Eligible and analyzable patients were included in this measure.

Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Measure	Premetrexed n=24 Participants Pemetrexed Disodium 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Overall Survival	25 months Interval 15.0 to 36.0

SECONDARY outcome

Timeframe: 0 - 3 years

Population: Eligible and analyzable patients were included in this measure.

Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

Outcome measures

Measure	Premetrexed n=24 Participants Pemetrexed Disodium 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Progression-free Survival	6 months Interval 3.0 to 14.0

SECONDARY outcome

Timeframe: Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.

Population: Eligible and analyzable patients with measurable disease at baseline are included in this measure.

Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

Outcome measures

Measure	Premetrexed n=17 Participants Pemetrexed Disodium 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Response (Confirmed and Unconfirmed, Complete and Partial)	29 percentage of participants Interval 10.0 to 56.0

SECONDARY outcome

Timeframe: Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.

Population: Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Outcome measures

Measure	Premetrexed n=24 Participants Pemetrexed Disodium 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Neutrophils/granulocytes (ANC/AGC)	3 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug ALT, SGPT (serum glutamic pyruvic transaminase)	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug AST, SGOT	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Diarrhea	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dyspnea (shortness of breath)	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fatigue (asthenia, lethargy, malaise)	3 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Febrile neutropenia	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Glucose, serum-high (hyperglycemia)	3 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hemoglobin	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Inf (clin/microbio) w/Gr 3-4 neuts - Skin	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Leukocytes (total WBC)	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Lymphopenia	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Platelets	2 Participants

Adverse Events

Pemetrexed

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pemetrexed n=24 participants at risk Pemetrexed Disodium 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Blood and lymphatic system disorders Hemoglobin	54.2% 13/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Gastrointestinal disorders Constipation	45.8% 11/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Gastrointestinal disorders Diarrhea	29.2% 7/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Oral cavity	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Gastrointestinal disorders Nausea	45.8% 11/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Gastrointestinal disorders Vomiting	25.0% 6/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
General disorders Edema: limb	16.7% 4/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
General disorders Fatigue (asthenia, lethargy, malaise)	66.7% 16/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	54.2% 13/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	37.5% 9/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Investigations Alkaline phosphatase	20.8% 5/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Investigations Leukocytes (total WBC)	12.5% 3/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Investigations Lymphopenia	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Investigations Neutrophils/granulocytes (ANC/AGC)	20.8% 5/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Investigations Platelets	12.5% 3/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Investigations Weight gain	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	12.5% 3/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Metabolism and nutrition disorders Anorexia	33.3% 8/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Metabolism and nutrition disorders Dehydration	12.5% 3/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	29.2% 7/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	12.5% 3/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Nervous system disorders Neuropathy: sensory	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Nervous system disorders Pain - Head/headache	20.8% 5/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Nervous system disorders Taste alteration (dysgeusia)	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Psychiatric disorders Insomnia	16.7% 4/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	8.3% 2/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 4/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	20.8% 5/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Skin and subcutaneous tissue disorders Rash/desquamation	12.5% 3/24 • Patients were assessed for adverse events after completion of each cycle of treatment.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	12.5% 3/24 • Patients were assessed for adverse events after completion of each cycle of treatment.

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place