Trials / Completed

CompletedNCT01440998

Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

Pilot and Translational Study of Dasatinib (NSC#732517) Paclitaxel and Carboplatin in Women With Advanced Stage and Recurrent Endometrial Cancer

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 18 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This pilot phase I trial studies how well dasatinib works together with paclitaxel and carboplatin in treating patients with stage III, stage IV, or endometrial cancer that has come back after a period of improvement. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving dasatinib together with paclitaxel and carboplatin may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate pMEK and EphA2 signaling effectors in pre- and post- treatment biopsy tissues from patients with advanced staged measurable primary or recurrent endometrial cancer. SECONDARY OBJECTIVES: I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4 (CTCAE v. 4) of dasatinib administered in combination with paclitaxel and carboplatin in patients with advanced staged measurable primary or recurrent endometrial cancer. II. To record the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. III. To describe the progression-free survival and overall survival. TERTIARY OBJECTIVES: I. To explore the relationship of micro ribonucleic acid (RNA) 520d-3p (miR520d-3p) and EphA2 in pretreatment biopsies. II. To evaluate downstream EphA2 signaling effectors, such as CAV-1, pAKT, FAK, paxillin, and p130cas in pre- and post-tissue treatment biopsies. III. To explore the effect of dasatinib on the expression of other Eph family members such as EphB2 and EphB4. IV. To quantify circulating tumor cells (CTCs) before and during the individual treatment phases. OUTLINE: Patients receive induction therapy comprising dasatinib orally (PO) once daily (QD) for 14 days. \*Beginning 7 days later, patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV on day 1, and dasatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. NOTE: \* Patients who have had prior external-beam pelvic or extended-field pelvic/para-aortic radiation therapy must receive treatment at a reduced dose. After completion of study treatment, patients are followed up every 3 months for 1 year.

Conditions

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Dasatinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given IV

Timeline

Start date: 2011-09-20
Primary completion: 2015-12-31
Completion: 2015-12-31
First posted: 2011-09-27
Last updated: 2018-04-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01440998. Inclusion in this directory is not an endorsement.