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A Phase II Study of UCN-01 in Combination With Topotecan in Patients With SCLC Who Relapsed or Progressed >= 3 Months After Completing First-Line Platinum-Based Chemotherapy

Phase 2
18 Years
Not Enrolling
Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

Thank you

Trial Information

A Phase II Study of UCN-01 in Combination With Topotecan in Patients With SCLC Who Relapsed or Progressed >= 3 Months After Completing First-Line Platinum-Based Chemotherapy


I. To determine the anti tumour activity of UCN-01 in combination with topotecan in patients
with SCLC who relapsed or progressed >= 3 months after completing first-line platinum-based
chemotherapy (patient with sensitive disease) using objective response rates (complete and


I. To determine the anti tumour activity of UCN-01 in combination with topotecan with
regards to stable disease rate, median and overall survival rates as well as to determine
the safety and tolerability of this combination.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day
1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression
or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR)
receive 2 additional courses beyond CR or PR.

Patients are followed for survival.

Inclusion Criteria:

- Patients must have histologically confirmed extensive stage small cell lung cancer
that is incurable but amenable to treatment with chemotherapy

- Patients must have measurable disease as defined by the Response Evaluation Criteria
in Solid Tumours (RECIST); they must have either measurable disease outside the field
or progression post radiation therapy

- Patient must have received ONLY first-line platinum-based chemotherapy and relapsed
or progressed >= 3 months post completion of therapy (patients with chemo-sensitive

- Patient must have completed any prior chemotherapy at least 3 months before study
entry, have completed surgery or radiotherapy at least 4 weeks before study entry and
must have recovered from the toxic effects from any prior therapy; patient must not
have had more than 40% of their bone marrow radiated

- ECOG performance status =< 2 (Karnofsky >= 60%)

- Leucocytes >= 3 x 10^9/L OR

- ANC >= 1.5 x 10^9/L

- Platelets >= 100 x 10^9/L

- Total serum bilirubin =< 1.5 x UNL

- AST/ALT =< 3 x UNL (=< 5 x UNL if documented liver metastases)

- Creatinine =< institutional upper limit of normal OR creatinine clearance >= 50
ml/min/1.73m^2 for patients with creatinine levels above institutional normal

- The effects of UCN-01 on the developing human fetus are unknown; for this reason,
women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control) prior to study entry and for the
duration of study participation; contraception should be continued at least 3 months
after the last dose of UCN-01; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had prior therapy with a topoisomerase I inhibitor (topotecan or
irinotecan) will be excluded

- Patients who have had other chemotherapy regimens other than first-line
platinum-based chemotherapy will be excluded

- Patients may not be receiving any other investigational agents

- Patients may not be receiving concurrent radiation therapy while on study treatment

- Patients with uncontrolled/symptomatic CNS metastases; routine CT scans are not
required to rule these out except when there is clinical suspicion of CNS disease

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to UCN-01 or other agents used in study

- Because of cardiopulmonary toxicity seen in patients on other studies, patients with
a history of coronary artery disease and/or symptomatic cardiac dysfunction should be

- Because UCN-01 may cause hyperglycemia, patients with insulin dependent diabetes
mellitus will be excluded; patients with diet-controlled diabetes mellitus or those
on oral hypoglycemic agents can be entered at the discretion of the investigator

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study because UCN-01 is a serine-threonine
kinase inhibitor with the potential for teratogenic or abortifacient effects; because
there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with UCN-01, breastfeeding should be
discontinued if the mother is treated with UCN-01; these potential risks may also
apply to other agents used in this study

- Because patients with immune deficiency are at increased risk of lethal infections
when treated with marrow-suppressive therapy, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with UCN-01 or other agents administered during the
study; appropriate studies will be undertaken in patients receiving combination
anti-retroviral therapy when indicated

- Patients may not have had any other active malignancy in the past 5 years except for
cervical carcinoma in situ and non-melanomatous skin cancer

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rates (complete and partial) evaluated using RECIST criteria

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Glennwood Goss

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital Phase 2 Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

Related Keywords:

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