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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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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


- 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

Inclusion Criteria


- 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


Biologic therapy:

- Prior maintenance therapy with biologic agents following first line chemotherapy

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Pierre Fumoleau, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre de Lutte Contre le Cancer Georges-Francois Leclerc


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma