Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006082
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: rubitecan Phase 2

Detailed Description:


  • 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2000
Actual Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


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


  • 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)


  • Creatinine no greater than 1.7 mg/dL


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


  • 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


Biologic therapy:

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


  • 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


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


  • Greater than 2 weeks since prior major surgery


  • No other concurrent anticancer therapy
  • No other concurrent investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006082

CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Pierre Fumoleau, MD, PhD Centre Georges Francois Leclerc

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00006082     History of Changes
Other Study ID Numbers: EORTC-16996SL
First Posted: May 22, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action