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
  Purpose

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:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006082

Locations
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Pierre Fumoleau, MD, PhD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00006082     History of Changes
Other Study ID Numbers: EORTC-16996SL, EORTC-16996SL
Study First Received: August 3, 2000
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
9-nitrocamptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014