Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer

A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00383331

Enrollment

Registered

2006-10-03

Start date

2007-02-28

Completion date

2008-01-31

Last updated

2009-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Cancer

Brief summary

This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.

Interventions

DRUGPemetrexed

A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles

DRUGGemcitabine

A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* histologic or cytologic diagnosis of NSCLC Stage IIIB or IV * no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer * Prior radiotherapy must be completed at least 4 weeks before study enrollment.

Exclusion criteria

* estimated life expectancy of 12 weeks * a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease * documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment * significant weight loss (that is, \> 10%) over the previous 6 weeks before study entry.

Design outcomes

Primary

Measure	Time frame	Description
Best Overall Tumor Response	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.

Secondary

Measure	Time frame	Description
Progression Free Survival	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	baseline to measured progressive disease
Time to Progressive Disease	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Time to progressive disease not analyzed because trial was stopped early due to low enrollment.
Duration of Response	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Duration of response was not analyzed because the trial was stopped early due to low enrollment.
Time to Treatment Failure	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.
Overall Survival	baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up	Survival time is defined as the time from date of randomization to death due to any cause.

Countries

United States

Participant flow

Participants by arm

Arm	Count
21-Day Cycle Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles	10
14-Day Cycle Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles	9
Total	19

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	0	1

Baseline characteristics

Characteristic	14-Day Cycle	Total	21-Day Cycle
Age Continuous	63.0 years	66.0 years	70.5 years
Eastern Cooperative Oncology Group Performance Score 0 - Fully Active	4 participants	8 participants	4 participants
Eastern Cooperative Oncology Group Performance Score 1 - Ambulatory, Restricted Strenuous Activity	5 participants	11 participants	6 participants
Eastern Cooperative Oncology Group Performance Score 2 - Amublatory, No Work Activities	0 participants	0 participants	0 participants
Eastern Cooperative Oncology Group Performance Score 3 - Partially Confined to Bed, Limited Self Care	0 participants	0 participants	0 participants
Eastern Cooperative Oncology Group Performance Score 4 - Completely Disabled	0 participants	0 participants	0 participants
Previous Radiation Therapy No	8 participants	15 participants	7 participants
Previous Radiation Therapy Yes	1 participants	4 participants	3 participants
Region of Enrollment United States	9 participants	19 participants	10 participants
Sex: Female, Male Female	3 Participants	8 Participants	5 Participants
Sex: Female, Male Male	6 Participants	11 Participants	5 Participants
Stage of Lung Cancer IIIB with pleural effusion	2 participants	4 participants	2 participants
Stage of Lung Cancer IV	7 participants	15 participants	8 participants
Tumor Cell Type Adenocarcinoma	3 participants	8 participants	5 participants
Tumor Cell Type Non-Small Cell Lung, Not Otherwise Specified (NOS)	2 participants	6 participants	4 participants
Tumor Cell Type Other	2 participants	2 participants	0 participants
Tumor Cell Type Squamous	2 participants	3 participants	1 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	10 / —	9 / —
serious Total, serious adverse events	9 / —	4 / —

Outcome results

Primary

Best Overall Tumor Response

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.