First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC

Conditions

• Lung Cancer

Eligibility Criteria

Sex

ALL

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemetrexed — DRUG
  pemetrexed 500 mg/m2
• Gemcitabine — DRUG
  gemcitabine 1500 mg/m2
• Bevacizumab — DRUG
  bevacizumab 10mg/kg bevacizumab 15mg/kg
• Carboplatin — DRUG
  carboplatin AUC=5

Study Details

This trial will look at 2 different drug combinations that have well known safety profiles and are known to be active against non small cell lung cancer and combine them with bevacizumab, an experimental drug that has shown effectiveness when added to other drug combinations for advanced non-small cell lung cancer. The primary objective in this study is to see how well this combination of drugs keeps the cancer from getting worse in this elderly population of non-small cell lung cancer patients.

Key Dates

First listed

Apr 4, 2007

Start date

Mar 31, 2007

Status verified

Apr 2022

Primary completion

Feb 28, 2010

Completion

Sep 30, 2012

Study Design

Enrollment

110 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A
  Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
• Experimental: Cohort B
  Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.

Primary Outcome Measure

Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months ]

Locations (18)

Find similar trials in Anniston, AL

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