Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer

NCT00075400 | Completed Phase 2 Results

• 4 other identifiers: NCI-2014-00653CDR0000346361GOG-0230CU10CA027469
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II clinical trial studies the side effects and how well imatinib mesylate works in treating patients with uterine cancer that has failed to respond to initial chemotherapy or has re-grown after therapy. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Uterine Sarcoma; Uterine Carcinosarcoma

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS) > 6 Months

  Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

  For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.

• Incidence of Adverse Effects as Assessed by CTCAE v 3.0

  The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.

  Each cycle during treatment and 30 days after treatment ends.

Secondary Outcomes (5)

• Tumor Response

  CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years

• Overall Survival

  From study entry to death or last contact, up to 5 years.

• Duration of Progression Free Survival

  CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years

• Initial Performance Status

  Baseline

• Initial Histologic Grade

  Baseline

Other Outcomes (4)

• PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC

  Baseline

• AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC

  Baseline

• p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue

  Baseline

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

Patients receive imatinib mesylate PO QD or BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: imatinib mesylate; Other: laboratory biomarker analysis

Interventions

imatinib mesylate DRUG

Given PO

Also known as: CGP 57148, Gleevec, Glivec

Treatment (imatinib mesylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (imatinib mesylate)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed uterine carcinosarcoma that is persistent or recurrent with documented disease progression after appropriate local therapy; acceptable histologic type is defined as carcinosarcoma (malignant mixed Mullerian tumor), homologous or heterologous type
• All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT
• Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST; tumors within a previously irradiated field will be designated as "non-target" lesions
• Patients must not be eligible for a higher priority Gynecological Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population
• Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1
• Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• Patients should be free of active infection requiring antibiotics
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
• Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
• Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
• Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
• Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
• Note: Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy
• Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease
• Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to CTCAE v3.0 grade 1

You may not qualify if:

• Patients who had previous treatment with Gleevec\^TM
• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
• Patients with signs or symptoms of bowel dysfunction or obstruction
• Patients receiving therapeutic anticoagulation with warfarin
• Patients with deep venous or arterial thrombosis (including pulmonary embolism) within six weeks of study entry
• Patients receiving therapeutic corticosteroids
• Patients with active or uncontrolled infection
• History of seizures or those patients receiving phenytoin, phenobarbital, or carbamazepine
• Patients with other severe concurrent disease, which the investigator feels may make the patients inappropriate for study entry
• Presence of clinically apparent central nervous system metastases, or other carcinomatous meningitis
• History of myocardial infarction within previous six months or congestive heart failure requiring therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Angela M. Kuras, Associate Director of Data Management
• Organization: NRG Oncology Statistics and Data Management Center - Buffalo

kurasa@nrgoncology.org

716-845-7733

Study Officials

• Warner Huh

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 12, 2004
• Study Start: January 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 24, 2019
• Results First Posted: May 22, 2015

Record last verified: 2019-07

Locations

US (1)