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A Randomized Phase II Trial Of ALIMTA/Cisplatin And ALIMTA/Carboplatin In Extensive Stage Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Randomized Phase II Trial Of ALIMTA/Cisplatin And ALIMTA/Carboplatin In Extensive Stage Small Cell Lung Cancer


- Determine the antitumor activity of pemetrexed disodium and cisplatin or pemetrexed
disodium and carboplatin, as measured by the complete and partial tumor response rate,
in patients with extensive stage small cell lung cancer.

- Determine the duration of response in patients treated with these regimens.

- Determine the time to progression in patients treated with these regimens.

- Determine the survival time in patients treated with these regimens.

- Determine the quantitative and qualitative toxic effects of these regimens in these

OUTLINE: This is an open-label, randomized study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive pemetrexed disodium IV over 8-15 minutes and cisplatin IV over
1 hour on day 1.

- Arm II: Patients receive pemetrexed disodium as in arm I and carboplatin IV over 1 hour
on day 1.

In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 6 weeks for 6 months, and then every 12 weeks for 12 months.

PROJECTED ACCRUAL: A total of 34-72 patients (17-36 per treatment arm) will be accrued for
this study.

Inclusion Criteria


- Histologically or cytologically confirmed small cell lung cancer (SCLC)

- Extensive stage, including malignant pleural effusion

- Measurable disease

- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques or 10 mm by spiral CT scan*

- Chest x-rays are acceptable if the lesions are clearly defined and
surrounded by aerated lung

- Clinically detected lesions must be superficial (e.g., skin nodules or
palpable lymph nodes) to be considered measurable

- Skin lesions are to be documented by color photography, including a ruler
to estimate the size of the lesion NOTE: *A solitary measurable lesion must
be histologically or cytologically confirmed

- No symptomatic brain metastases

- No clinically relevant third-space fluid collections (e.g., ascites or pleural
effusions) by physical examination that cannot be controlled by drainage or other



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 3.0 times ULN*

- Alkaline phosphatase no greater than 3.0 times ULN* NOTE: *5 times ULN if liver has
tumor involvement


- Creatinine clearance at least 45 mL/min


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

- Able and willing to take folic acid, cobalamin (vitamin B_12), or dexamethasone

- Able to tolerate interruption of aspirin or other nonsteroidal anti-inflammatory
agents for a 5-day period (8-day period for long-acting agents such as piroxicam)

- No second primary malignancy except the following:

- Carcinoma in situ of the cervix

- Adequately treated nonmelanoma skin cancer

- Prior low-grade (Gleason score no greater than 6) localized prostate cancer

- Other previously treated malignancy with no evidence of recurrence within the
past 5 years

- No active infection

- No other serious concurrent systemic disorder that would preclude patient safety or
study completion


Biologic therapy

- No prior systemic biologic therapy for SCLC

- No prior systemic immunotherapy for SCLC

- No concurrent prophylactic filgrastim (G-CSF)

- No concurrent thrombopoiesis stimulators

- No concurrent immunotherapy


- No prior systemic chemotherapy for small cell lung cancer

- No prior pemetrexed disodium

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal cancer therapy


- No prior radiotherapy

- No concurrent radiotherapy


- No concurrent anticancer surgery


- More than 30 days since prior investigational drugs

- No prior enrollment on this study

- No other concurrent experimental medications (except thymidine)

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Diane Prager, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781