Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ)

Conditions

• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin AUC — DRUG
  Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.
• Paclitaxel — DRUG
  Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.
• lapatinib — DRUG
  Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.

Study Details

RATIONALE: Since lapatinib inhibits both EGFR and HER2 receptors, it is an attractive agent for the treatment of esophageal and GEJ tumors. PURPOSE: Lapatinib is currently approved for HER2 positive metastatic breast cancer in combination with capecitabine or letrozole. It is hoped that by giving lapatinib and carboplatin and paclitaxel together, their combined effects will further slow or stop the cancer cells from growing.

Key Dates

Start date

Aug 31, 2011

Status verified

Mar 2019

Primary completion

Dec 31, 2014

Completion

Dec 31, 2014

Study Design

Enrollment

13 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lapatinib With Carboplatin and Paclitaxel

Primary Outcome Measure

PHASE I: Number of Patients That Experience a Grade 3-4 Dose Limiting Toxicity [ Time Frame: after 9 weeks (3 cycles) of treatment ]

Locations (2)

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