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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: rubitecan

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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nantes-Saint Herblain, France, 44805
    • CRLCC Nantes - Atlantique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Study Chair: Pierre Fumoleau, MD, PhD, Centre Georges François Leclerc

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Primary Completion (Actual): August 1, 2002

Study Registration Dates

• First Submitted: August 3, 2000
• First Submitted That Met QC Criteria: May 21, 2003
• First Posted (Estimate): May 22, 2003

Study Record Updates

• Last Update Posted (Estimate): September 24, 2012
• Last Update Submitted That Met QC Criteria: September 20, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: extensive stage small cell lung cancer; recurrent small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Rubitecan
• Other Study ID Numbers: EORTC-16996SL