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Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00006082
First received: August 3, 2000
Last updated: September 20, 2012
Last verified: September 2012

August 3, 2000
September 20, 2012
May 2000
August 2002   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00006082 on ClinicalTrials.gov Archive Site
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Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer
Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On - 2 Days Off" Oral Treatment in Advanced Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced small cell lung cancer.

OBJECTIVES:

  • Determine the objective response and duration of objective response in patients with advanced small cell lung cancer treated with nitrocamptothecin.
  • Determine the probability of objective response as expressed by the response rate in patients treated with this regimen.
  • Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory).

Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past CR or PR.

Patients are followed every 6 weeks until disease progression or initiation of another antitumor treatment.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for the sensitive disease stratum and a total of 19-24 patients will be accrued for the refractory disease stratum

Interventional
Phase 2
Primary Purpose: Treatment
Lung Cancer
Drug: rubitecan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
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August 2002   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven advanced (extensive stage) small cell lung cancer with progressive or recurrent disease after 1 first line chemotherapy regimen

    • Sensitive disease, defined as a response to prior chemotherapy lasting at least 3 months from the end of all prior treatment, including radiotherapy, until the time of progression OR
    • Refractory disease, defined as no response to prior chemotherapy, or a response to prior chemotherapy followed by progression within 3 months after completion of all prior therapy, including radiotherapy
  • Minimum of 1 target lesion that can be accurately measured in at least 1 dimension

    • 20 mm or more with conventional techniques OR
    • 10 mm or more with spiral CT scans
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present)

Renal:

  • Creatinine no greater than 1.7 mg/dL

Cardiovascular:

  • No ischemic heart disease within the past 6 months
  • Normal 12 lead electrocardiogram

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior or concurrent malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
  • No unstable systemic disease or active uncontrolled infection
  • No psychological, familial, sociological, or geographical condition that may preclude compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior maintenance therapy with biologic agents following first line chemotherapy allowed
  • No concurrent filgrastim (G-CSF) with nitrocamptothecin

Chemotherapy:

  • See Disease Characteristics
  • Greater than 4 weeks since prior chemotherapy
  • No more than 1 prior chemotherapy regimen for extensive disease
  • Alternate or sequential use of different regimens without interruption in first line treatment is considered 1 first line therapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • Greater than 4 weeks since prior radiotherapy

Surgery:

  • Greater than 2 weeks since prior major surgery

Other:

  • No other concurrent anticancer therapy
  • No other concurrent investigational therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00006082
EORTC-16996SL, EORTC-16996SL
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Pierre Fumoleau, MD, PhD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
European Organisation for Research and Treatment of Cancer - EORTC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP