Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00006082

Collaborator

(none)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: rubitecan	Phase 2

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 Design

Study Type:

Interventional

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 1, 2000

Actual Primary Completion Date :

Aug 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 Georges Francois Leclerc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

European Organisation for Research and Treatment of Cancer - EORTC

ClinicalTrials.gov Identifier:

NCT00006082

Other Study ID Numbers:

EORTC-16996SL
EORTC-16996SL

First Posted:

May 22, 2003

Last Update Posted:

Sep 24, 2012

Last Verified:

Sep 1, 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

Rubitecan

Study Results

No Results Posted as of Sep 24, 2012