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Extensive Stage Small Cell Lung CancerPhase 2NCT00773955

R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

A Phase 2 study testing R-(-)-gossypol acetic acid, pharmacological study and laboratory biomarker analysis 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 United States.

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 R-(-)-gossypol acetic acid works in treating patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
R-(-)-gossypol acetic acid, pharmacological study and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Nov 2008to Aug 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

  • Histologically or cytologically confirmed small cell lung cancer
  • Extensive stage disease
  • Recurrent disease
  • Measurable disease
  • Chemotherapy-sensitive disease, defined as:
  • No progression during first-line chemotherapy
Show all 49Show fewer
  • No disease recurrence < 2 months after completion of first-line chemotherapy
  • Must have received prior platinum-based chemotherapy
  • No symptomatic or progressive brain metastases
  • Patients with previously treated brain metastases who are clinically and radiographically stable or improved and have been off steroids ≥ 14 days are eligible
  • ECOG performance status 0-2
  • Life expectancy > 12 weeks
  • Leukocytes ≥ 3,000/μL
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Total bilirubin < 1.5 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  • Hemoglobin > 8 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception before, during, and for 30 days after completion of study therapy
  • Able to take oral medications on a regular basis
  • Willing to provide blood samples for mandatory correlative studies
  • No condition that impairs the ability to swallow and retain R-(-)-gossypol tablets, including the following:
  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
  • Active peptic ulcer disease
  • No malabsorption syndrome or disease significantly affecting gastrointestinal function
  • No ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction
  • No uncontrolled concurrent illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would limit compliance with study requirements
  • No symptomatic hypercalcemia > grade 2
  • No requirement for routine use of hematopoietic growth factors (including G-CSF, GM-CSF, or IL-11) or platelet transfusions to maintain ANC or platelet counts
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to R-(-)-gossypol
  • No HIV positivity
  • Recovered from all prior therapy, including prior surgical procedures
  • No prior surgical procedures affecting absorption
  • No prior resection of the stomach or small bowel
  • No more than one prior chemotherapy regimen
  • No prior racemic gossypol or R-(-)-gossypol
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • At least 4 weeks since prior radiotherapy, hormonal agents, or biologic response modifiers
  • At least 4 weeks since prior and no concurrent investigational agents or devices
  • No concurrent prophylactic hematopoietic growth factors (including filgrastim [G-CSF], sargramostim [GM-CSF], or interleukin-11 [IL-11]) during course one
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Study of AT-101 in Recurrent Extensive Stage Small Cell Lung Cancer

This phase II trial is studying how well R-(-)-gossypol acetic acid works in treating patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the objective response rate of R-(-)-gossypol in patients with recurrent chemotherapy-sensitive extensive stage small cell lung cancer.

II. To determine the time to disease progression. III. To determine the overall survival. IV. To assess the toxicities associated with this drug. V. To explore whether intratumoral Bcl-2 family member expression correlates with sensitivity to targeting by R-(-)-gossypol.

VI. To explore whether the administration of R-(-)-gossypol causes specific induction of the intrinsic apoptotic pathway.

OUTLINE: This is a multicenter study.

Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically during treatment for pharmacodynamic analysis. Peripheral blood mononuclear cells are analyzed via protein isolation and western blotting for Bcl-2, cytoplasmic release of cytochrome c, and caspase activation. Available tumor tissue blocks are assessed by immunohistochemistry.

After completion of study therapy, patients are followed periodically for up to 5 years.

Being tested
R-(-)-gossypol acetic acid, pharmacological study, laboratory biomarker analysis
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.

  • R-(-)-gossypol acetic acidDrug

    Also called AT-101

    Given orally

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00773955
Study groupRoleWhat they receive
Treatment (R-(-)-gossypol)ExperimentalPatients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: R-(-)-gossypol acetic acid; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

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

  1. Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)

    The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:

    A Complete Response (CR) requires the disappearance of all target lesions

    A Partial Response (PR) requires a >=30% decrease in the sum of the longest diameter of target lesions from baseline measurements.

    Measured: During the first 6 courses of treatment

Secondary outcomes (3)

  1. Survival Time

    Estimated using the method of Kaplan-Meier.

    Measured: From registration to death due to any cause, assessed up to 5 years

  2. Time to Disease Progression

    Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. Estimated using the method of Kaplan-Meier.

    Per the RECIST criteria, progression is defined as at least a 20% increase in the sum of Longest Dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: From registration to the earliest date documentation of disease progression, assessed up to 5 years

  3. Duration of Response

    Measured: From the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed 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 posted16 Oct 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionOct 2009
  4. Study completionAug 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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00773955
Sponsor's protocol ID
NCI-2009-01058
Other IDs
NCI-2009-01058, MAYO-MC0721, CDR0000616965, MC0721, 8027, N01CM62205, P30CA015083, N01CM62209
Status last verified
Oct 2011
First submitted
15 Oct 2008
Last updated
12 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing R-(-)-gossypol acetic acid, pharmacological study and laboratory biomarker analysis 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 United States.

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 49 inclusion and 0 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 12 May 2014. 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 United States. 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 21 Mar 2013). 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?

Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR) (time frame: During the first 6 courses of treatment). 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 NCT00773955.

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 12 May 2014.

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