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A Phase I Study of Weekly Doxorubicin and Oral Topotecan for Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)


Phase 1
19 Years
N/A
Open (Enrolling)
Both
Recurrent Small Cell Lung Cancer

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Trial Information

A Phase I Study of Weekly Doxorubicin and Oral Topotecan for Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)


PRIMARY OBJECTIVES:

I. Evaluate the safety and efficacy, in terms of clinical disease benefit (complete or
partial response and stable disease with stable or improved quality of life scores), of
treatment with doxorubicin hydrochloride and topotecan hydrochloride in patients with
relapsed or refractory small cell lung cancer.

II. Determine the dose-limiting toxicity of topotecan hydrochloride administered in
combination with doxorubicin hydrochloride in these patients.

SECONDARY OBJECTIVES:

I. Estimate topoisomerase I and II levels in peripheral blood mononuclear cells and
correlate them with the presence or absence of grades 3 and 4 hematological toxicity.

II. Estimate topoisomerase I and II levels in peripheral blood mononuclear cells and
correlate them with efficacy.

OUTLINE: This is a dose-escalation study of topotecan hydrochloride.

Patients receive doxorubicin hydrochloride IV weekly beginning on day 6 in weeks 1-15.
Patients also receive oral topotecan hydrochloride on days 1-5 in weeks 1, 4, 7, 10, and 13
in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline, and at weeks 7 and 16 to measure topoisomerase I
and II levels. Patients also complete the FACT-L quality of life questionnaire at baseline,
and at weeks 7 and 16.

After completion of study treatment, patients are followed every 2 months


Inclusion Criteria:



- Pathologically proven diagnosis of small cell lung cancer (SCLC)

- Have received at least one prior chemotherapy regimen for SCLC

- Primarily refractory or relapsed disease

- Measurable disease in 2 dimensions on imaging studies performed within 4 weeks of
starting treatment

- Greater than 2 weeks since last treatment (chemotherapy or radiation) provided
subject has recovered from side effects of treatment prior to the study

- Karnofsky score >= 70 (ECOG 0-2)

- No active secondary malignancy; patients with other prior malignancies will be
included, provided they have been disease-free for at least five years

- Patients with adequately treated basal cell or squamous cell carcinoma of the skin,
adequately treated non-invasive carcinomas will be eligible

- WBC count >= 3,500/mm^3 , OR absolute neutrophil count (ANC) >= 1,500/ul and platelet
count >= 100,000/mm^3 within 7 days prior to starting treatment

- Serum creatinine less than 1.5 times the upper limits of normal within 7 days prior
to starting treatment

- Serum AST and ALT less than 1.5 times the upper limits of normal, serum alkaline
phosphatase less than 2.5 times the upper limits of normal within 7 days prior to
starting treatment in the absence of liver metastasis; in the presence of liver
metastasis serum AST, ALT and alkaline phosphatase less than or equal to 5.0 times
the upper limits of normal within 7 days prior to starting treatment

- Women of child-bearing potential must have a negative pregnancy test within 7 days of
initiating study; (no childbearing potential is defined as age 55 years or older and
no menses for two years or any age with surgical removal of the uterus and/or both
ovaries)

- Non-pregnant and non-nursing; men and women of reproductive potential may not
participate unless they have agreed to use an effective contraceptive method while on
the study

- Able to return for treatment and follow-up as specified in the protocol

- Able to give informed consent

Exclusion Criteria:

- Known hypersensitivity to any component of topotecan or doxorubicin or other required
drugs in the study

- Any co morbidity or condition which, in the opinion of the investigator, may
interfere with the assessments and procedures of this protocol

- Ejection fraction below the lower limit of normal (< 50%)

- Uncontrolled intercurrent illnesses including, but not limited to unstable angina or
uncontrolled cardiac arrhythmia, chronic liver disease, complete left bundle branch
block, obligate use of a cardiac pacemaker, ST depression of > 1 mm in two or more
leads and/or T wave inversions in two or more contiguous leads, congenital long QT
syndrome, history of or presence of significant ventricular or atrial
tachyarrhythmias, clinically significant resting bradycardia (< 50 beats per minute),
QTc > 480 ms on screening electrocardiogram that could jeopardize the patient's
ability to receive the chemotherapy described in the protocol safely

- Women who are pregnant (confirmed by a serum pregnancy test in females of
reproductive potential) or breast-feeding; women of child-bearing potential and
sexually active males must be advised to take precautions to prevent pregnancy during
treatment (unless the subject or subject's partner(s) is sterile (i.e. women who have
had a hysterectomy or have been post-menopausal for at least twelve consecutive
months) or remain abstinent, men and women of reproductive potential must agree to
use TWO of the following forms of birth control every time they have sex throughout
the study and for up to 3 months following discontinuation of study drug: condoms
(male or female) with or without a spermicidal agent, diaphragm or cervical cap with
spermicidal, IUD, or surgical sterilization while participating in this study;
hormonal birth control methods are not permitted

- Inability to co-operate with the requirements of the protocol

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and efficacy of this regimen as assessed by the maximum tolerated dose (MTD) of the next lowest dose level below where greater than or equal to 2/3 or 3/6 patients experience dose limiting toxicities (DLT) in cohorts of 5 different doses

Outcome Time Frame:

After 2 cycles

Safety Issue:

Yes

Principal Investigator

Apar Ganti

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Institutional Review Board

Study ID:

508-08

NCT ID:

NCT00856037

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Recurrent Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680