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Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
rubitecan
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CRLCC Nantes - Atlantique

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00006082
Brief Title
Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rubitecan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Fumoleau, MD, PhD
Organizational Affiliation
Centre Georges Francois Leclerc
Official's Role
Study Chair
Facility Information:
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

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Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

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