This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

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

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 Intervention Phase
Lung Cancer Drug: rubitecan Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 38
Study Start Date: May 2000
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00006082     History of Changes
Other Study ID Numbers: EORTC-16996SL
Study First Received: August 3, 2000
Last Updated: September 20, 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 processed this record on August 17, 2017