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Trial Outcomes & Findings for Alimta Plus Gemcitabine for Advanced Sarcoma (NCT NCT00860015)

NCT ID: NCT00860015

Last Updated: 2020-08-25

Results Overview

The best response rate will include patients with both Complete Response and Partial Response after 2 months of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Two months

Results posted on

2020-08-25

Participant Flow

Participant milestones

Participant milestones
Measure
Alimta/Gemcitabine
IV administration of drugs for 14 days for up to 4 cycles Alimta: 500 mg/m2 via IV over 10 minutes A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer. Gemcitabine: 1000 mg/m2 via IV over 90 minutes A nucleoside analog used as chemotherapy.
Overall Study
STARTED
12
Overall Study
COMPLETED
12
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alimta Plus Gemcitabine for Advanced Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Alimta/Gemcitabine
n=12 Participants
IV administration of drugs for 14 days for up to 4 cycles Alimta: 500 mg/m2 via IV over 10 minutes A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer. Gemcitabine: 1000 mg/m2 via IV over 90 minutes A nucleoside analog used as chemotherapy.
Age, Customized
18-65 years
10 Participants
n=5 Participants
Age, Customized
> 65 years
2 Participants
n=5 Participants
Sex/Gender, Customized
Females
8 Participants
n=5 Participants
Sex/Gender, Customized
Males
4 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
8 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
3 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: Two months

The best response rate will include patients with both Complete Response and Partial Response after 2 months of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure
Alimta/Gemcitabine
n=12 Participants
IV administration of drugs for 14 days for up to 4 cycles Alimta: 500 mg/m2 via IV over 10 minutes A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer. Gemcitabine: 1000 mg/m2 via IV over 90 minutes A nucleoside analog used as chemotherapy.
Tumor Best Response Rate
0 Participants

Adverse Events

Alimta/Gemcitabine

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Alimta/Gemcitabine
n=12 participants at risk
IV administration of drugs for 14 days for up to 4 cycles Alimta: 500 mg/m2 via IV over 10 minutes A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer. Gemcitabine: 1000 mg/m2 via IV over 90 minutes A nucleoside analog used as chemotherapy.
General disorders
Infection
8.3%
1/12 • Number of events 1 • Two months
Gastrointestinal disorders
Constipation
8.3%
1/12 • Number of events 1 • Two months

Additional Information

Rober Taub, MD - Vivian and Seymour Milstein Family Prof. of Clinical Medicine

Columbia University

Results disclosure agreements

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