Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2024-05-17

Brief Summary

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This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

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Detailed Description

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While ABCB1 (P-glycoprotein 1) upregulation after paclitaxel administration is well known, there is currently no clinically available method for preventing or overcoming it. To develop a therapy able to prevent ABCB1 upregulation and paclitaxel resistance, several ABCB1 inhibitors have been evaluated in combination with paclitaxel in preclinical model systems. Pulsed-dose lapatinib and paclitaxel are synergistic and inhibition of ABCB1 by lapatinib increases sensitivity to paclitaxel. Lapatinib is FDA approved, orally available, and previously studied in combination with weekly paclitaxel for breast cancer at doses of 1000mg to 1250mg daily (7000-8250mg per week). This trial will use twice-daily dosing of lapatinib at a starting dose of 750 mg for 2 days (1500mg a day and 3000mg weekly dose), which is less than half of the continuous dose and has been shown to achieve plasma concentrations at 48 hours that are associated with synergy. Therefore, these findings can be translated into a novel, well-tolerated, and convenient combination regimen with significant potential for clinical activity. This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lapatinib - Group 1

Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2).

Group Type EXPERIMENTAL

Lapatinib and Paclitaxel

Intervention Type DRUG

Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.

Lapatinib - Group 2

Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2).

Group Type EXPERIMENTAL

Lapatinib and Paclitaxel

Intervention Type DRUG

Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.

Lapatinib - Group 3

Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).

Group Type EXPERIMENTAL

Lapatinib and Paclitaxel

Intervention Type DRUG

Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.

Interventions

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Lapatinib and Paclitaxel

Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* histologically or cytologically confirmed ovarian cancer who recur within 12 months of platinum-based chemotherapy
* ECOG performance status less than or equal to 2
* Adequate organ and marrow function at baseline
* ability to sign a written informed consent document

Exclusion Criteria

* hypersensitivity to lapatinib or paclitaxel
* uncontrolled intercurrent illness
* receiving medications that inhibit or induce CYP3A4
* malabsorption syndrome
* congestive heart failure
* receiving any other anti-cancer investigational agents
* baseline neuropathy greater than Grade 1

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No