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Gemcitabine in Combination With Pemetrexed Long Term Infusion in the Treatment of Pretreated Metastatic Colorectal Cancer Patients

NCT01909830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-06-19

No results posted yet for this study

Summary

Study Design:

Multicenter, non randomized, open label phase II study designed to evaluate the efficacy and safety of Gemcitabine/Pemetrexed combination.

Enrollment period: 18 months. Treatment period: maximum for 24 weeks for each patient (12 cycles lasting 2 weeks).

Total duration of the study: 24 months.

Number of Subjects:

Approximately 38 subjects will be enrolled on study:

\- First stage:12 patients enrolled

If 1 or 0 responses were observed, the trial had to be terminated:

\- Second stage: an additional of 23 patients were to be enrolled. If 5 or less responses were observed in 35 patients, the combination would not be considered worthy of further study, while if 6 or more responses were observed, the combination would be considered sufficiently active to warrant further testing. Taking into account an invalidity rate of 5%, 38 patients will be needed for this step.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

Arm A : Gemcitabine + Pemetrexed

Gemcitabine: 1000 mg/m2 by intravenous infusion over an exact period of 30' (preferably by a pump to guarantee a constant speed of infusion) on day 3 of each cycle repeated every 14 days. Pemetrexed: 150 mg/m2 by intravenous continuous infusion over an exact period of 8h on day 1 of each cycle repeated every 14 days.

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Giovanni Luca Frassineti, MD · IRST IRCCS, Meldola

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01909830 on ClinicalTrials.gov