Trial · NCT01142388

Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

NCT01142388, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2015-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer. Trials, record NCT01142388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01142388

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
NCT number: NCT01142388
Status: Active not recruiting
Phases: Phase 2
Enrollment: 94 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Metastatic Esophageal Adenocarcinoma, Metastatic Esophageal Squamous Cell Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Recurrent Esophageal Adenocarcinoma, Recurrent Esophageal Carcinoma, Recurrent Esophageal Squamous Cell Carcinoma, Recurrent Gastroesophageal Junction Adenocarcinoma, Stage IV Esophageal Cancer AJCC v7
Interventions: Cixutumumab, Laboratory Biomarker Analysis, Paclitaxel, Pharmacological Study
First posted: 2010-06-11
Last updated: 2026-09-10
Results first posted: 2015-06-03

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival	assessed every 3 months for 2 years after registration	Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (4 months) following the date last known progression-free, in which case the death was counted as an event, or in the case of death within 4 months of randomization in the absence of disease evaluation before that time. PFS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood's formula, and compared by the log rank test.
Secondary	Overall Survival	assessed every 3 months for 2 years after registration	Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood's formula, and compared by the log rank test.
Secondary	Objective Response Rate	assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years	Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival	assessed every 3 months for 2 years after registration	Eligible patients.	months	MEDIAN
SECONDARY	Overall Survival	assessed every 3 months for 2 years after registration	Eligible patients	months	MEDIAN
SECONDARY	Objective Response Rate	assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years	Eligible patients	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-free Survival	Arm I (Paclitaxel)	2.6	90% Confidence Interval 1.8 to 4.1	months
Progression-free Survival	Arm II (Cixutumumab, Paclitaxel)	2.3	90% Confidence Interval 2.0 to 3.6	months
Overall Survival	Arm I (Paclitaxel)	6.5	90% Confidence Interval 4.6 to 9.5	months
Overall Survival	Arm II (Cixutumumab, Paclitaxel)	6.4	90% Confidence Interval 4.9 to 8.0	months
Objective Response Rate	Arm I (Paclitaxel)	12	90% Confidence Interval 5 to 23	percentage of participants
Objective Response Rate	Arm II (Cixutumumab, Paclitaxel)	14	90% Confidence Interval 6 to 25	percentage of participants

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Paclitaxel)	47
Overall Study	STARTED	Arm II (Cixutumumab, Paclitaxel)	47
Overall Study	Eligible	Arm I (Paclitaxel)	43
Overall Study	Eligible	Arm II (Cixutumumab, Paclitaxel)	44
Overall Study	Treated	Arm I (Paclitaxel)	40
Overall Study	Treated	Arm II (Cixutumumab, Paclitaxel)	44
Overall Study	COMPLETED	Arm I (Paclitaxel)	0
Overall Study	COMPLETED	Arm II (Cixutumumab, Paclitaxel)	0
Overall Study	NOT COMPLETED	Arm I (Paclitaxel)	47
Overall Study	NOT COMPLETED	Arm II (Cixutumumab, Paclitaxel)	47

Source ClinicalTrials.gov

Adverse events162

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Arm I (Paclitaxel)	29	40
other	Anemia	Blood and lymphatic system disorders	Arm II (Cixutumumab, Paclitaxel)	29	44
other	Edema limbs	General disorders	Arm I (Paclitaxel)	4	40
other	Edema limbs	General disorders	Arm II (Cixutumumab, Paclitaxel)	1	44
other	Fatigue	General disorders	Arm I (Paclitaxel)	27	40
other	Fatigue	General disorders	Arm II (Cixutumumab, Paclitaxel)	27	44
other	Alopecia	Skin and subcutaneous tissue disorders	Arm I (Paclitaxel)	13	40
other	Alopecia	Skin and subcutaneous tissue disorders	Arm II (Cixutumumab, Paclitaxel)	12	44
other	Pruritus	Skin and subcutaneous tissue disorders	Arm I (Paclitaxel)	3	40
other	Pruritus	Skin and subcutaneous tissue disorders	Arm II (Cixutumumab, Paclitaxel)	5	44

1 to 10 of 162Source ClinicalTrials.gov

See all 162 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Paclitaxel)
Total, all-cause mortality	Arm II (Cixutumumab, Paclitaxel)
Total, other adverse events	Arm I (Paclitaxel)	39	40
Total, other adverse events	Arm II (Cixutumumab, Paclitaxel)	43	44
Total, serious adverse events	Arm I (Paclitaxel)	21	40
Total, serious adverse events	Arm II (Cixutumumab, Paclitaxel)	23	44

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37104870	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180820	ECOG-ACRIN Network Group Operations Center	ODwyer, Peter J; SCHNALL, MITCHELL D.	ECOG-ACRIN MEDICAL RESEARCH FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA021115	Eastern Cooperative Oncology Group Operations Office	COMIS, ROBERT L	FRONTIER SCI & TECHNOLOGY RSCH FDN, INC	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Arm I (Paclitaxel) vs Arm II (Cixutumumab, Paclitaxel): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01142388

GET https://conductscience.org/api/trials/v1/NCT01142388/events?page=2

API reference For AI assistants