Trial Outcomes & Findings for Paclitaxel, Cisplatin, Gefitinib, and Radiation Therapy Followed by Surgery and Gefitinib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction That Can Be Removed By Surgery (NCT NCT00493025)

NCT ID: NCT00493025

Last Updated: 2018-12-06

Results Overview

Study closed due to early stopping rule. Patient data was not analyzed. No additional information is available to report

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2018-12-06

Participant Flow

Participant milestones

Measure	Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Posto ZD1839 paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 adjuvant therapy: Combined Modality Paclitaxel, Cisplatin,
Overall Study STARTED	19
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Posto ZD1839 paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 adjuvant therapy: Combined Modality Paclitaxel, Cisplatin,

Overall Study Physician Decision

19

Baseline Characteristics

Paclitaxel, Cisplatin, Gefitinib, and Radiation Therapy Followed by Surgery and Gefitinib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction That Can Be Removed By Surgery

Baseline characteristics by cohort

Measure	Paclitaxel, Cisplatin, ZD1839 and Radiotherapy n=19 Participants Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 cisplatin: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gefitinib: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 paclitaxel: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 gene expression analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 Radiotherapy Followed by Postoperative ZD1839 immunohistochemistry staining method: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 laboratory biomarker analysis: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 pharmacological study: Combined Modality Paclitaxel, Cisplatin, ZD1839 and Radiotherapy Followed by Postoperative ZD1839 adjuvant therapy: Combined Modality Paclitaxel, Cisplatin,
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 7.37 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure

Study closed due to early stopping rule. Patient data was not analyzed. No additional information is available to report

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Study terminated due to early stopping rule. Therefore, data was not collected to assess this outcome measure

Outcome measures

Outcome data not reported

Adverse Events

Paclitaxel, Cisplatin, ZD1839 and Radiotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rosalyn Juergens, MD.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 410-908-7829

Email: rjuerge1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place