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Extensive Stage Small Cell Lung CancerPhase 2NCT00098956

7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer

A Phase 2 study testing topotecan hydrochloride and 7-hydroxystaurosporine in people with Extensive Stage Small Cell Lung Cancer and Recurrent Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well giving UCN-01 together with topotecan works in treating patients with small cell lung cancer that relapsed or progressed after previous chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
topotecan hydrochloride and 7-hydroxystaurosporine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteCanada
Study dates
Jan 2005to Jun 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 disease)
  • 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
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  • 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 immediately
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • 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
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  • 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 excluded
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital Phase 2 Consortium

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

This phase II trial is studying how well giving UCN-01 together with topotecan works in treating patients with small cell lung cancer that relapsed or progressed after previous chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. UCN-01 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also increase the effectiveness of topotecan by making tumor cells more sensitive to the drug. Giving UCN-01 together with topotecan may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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 partial).

SECONDARY OBJECTIVES:

  1. 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.

Being tested
topotecan hydrochloride, 7-hydroxystaurosporine
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • topotecan hydrochlorideDrug

    Also called hycamptamine, Hycamtin, SKF S-104864-A, TOPO

    Given IV

  • 7-hydroxystaurosporineDrug

    Also called UCN-01

    Given IV

Study groups in NCT00098956
Study groupRoleWhat they receive
Treatment (topotecan hydrochloride, UCN-01)ExperimentalPatients 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 CR or PR receive 2 additional courses beyond CR or PR.
Receives: Drug: topotecan hydrochloride; Drug: 7-hydroxystaurosporine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

    Measured: Up to 5 years

Secondary outcomes (5)

  1. Stable Disease Rate Evaluated Using RECIST Criteria

    Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

    Measured: Up to 5 years

  2. Duration of Responses

    Measured: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years

  3. Progression-free Survival

    Measured: From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years

  4. Overall Survival

    Measured: From the date of enrollment to death or last contact, assessed up to 5 years

  5. Adverse Events, Graded Using the CTCAE Version 3.0

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2004 (estimated)
  2. Study startJan 2005
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098956
Sponsor's protocol ID
NCI-2012-03092
Other IDs
NCI-2012-03092, 6992, PHL032, 6992, N01CM62203
Status last verified
Jul 2018
First submitted
8 Dec 2004
Last updated
23 Jul 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing topotecan hydrochloride and 7-hydroxystaurosporine in people with Extensive Stage Small Cell Lung Cancer and Recurrent Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00098956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.

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