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Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

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

- Malignant pleural effusion constitutes extensive stage disease

- Must have disease outside area of prior surgical resection or a new lesion must be
present

- Controlled brain metastases allowed (asymptomatic and previously treated with surgery
and/or radiotherapy)

- Brain metastases must be re-evaluated by CT scan or MRI after completion of
radiotherapy or surgery

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

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

- WBC at least 3,000/mm^3

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

Hepatic:

- Bilirubin no greater than 1.25 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately
treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy for SCLC

Chemotherapy:

- No prior systemic chemotherapy for SCLC

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy for SCLC except for brain metastases

Surgery:

- See Disease Characteristics

- At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered

Gender: Both
Steward Physician(s)
  • Wallace L. Akerley, MD
Trial Interventions
Drug
  • gemcitabine hydrochloride
  • irinotecan hydrochloride
Physician Researcher

Investigator Name:

  • Wallace L. Akerley, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00030433
Volunteers:  Not Accepting Healthy Volunteers

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