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A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned

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Lilly

Status and phase

Completed
Phase 2

Conditions

Carcinoma, Small Cell

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191750
7209
H3E-US-S069

Details and patient eligibility

About

The purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of small cell lung cancer
  • One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment
  • At least 18 years of age
  • Estimated life expectancy of at least 12 weeks
  • Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours)

Exclusion criteria

  • Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication
  • Less than 2 weeks from radiation therapy
  • Other serious illness that would compromise the safety of the patient
  • Most second primary malignancies treated less than 5 years previously

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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