Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00077545
Other study ID # NCI-2012-02576
Secondary ID NCI-2012-02576CD
Status Completed
Phase Phase 2
First received February 10, 2004
Last updated October 7, 2013
Start date January 2004

Study information

Verified date October 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help cisplatin kill more cancer cells by making them more sensitive to the drug. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction.


Description:

PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine) and cisplatin.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients. II. Determine the duration of response and overall survival of patients treated with this regimen.

III. Determine the palliative benefits with regard to dysphagia in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 20 months.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction

- Metastatic or recurrent disease

- Measurable disease

- At least 1 unidimensionally measurable lesion = 20 mm by conventional techniques OR = 10 mm by spiral CT scan

- Outside prior irradiation port

- No known brain metastases

- Performance status - ECOG 0-2

- Performance status - Karnofsky 50-100%

- More than 6 months

- Absolute neutrophil count = 1,500/mm^3

- WBC = 3,000/mm ^3

- Platelet count = 100,000/mm^3

- AST and ALT = 2.5 times upper limit of normal

- Bilirubin normal

- Creatine normal

- Creatinine clearance = 50 mL/min

- No prior myocardial infarction

- No unstable angina

- No cardiac arrhythmia

- No uncontrolled congestive heart failure

- No pulmonary disease requiring supplemental oxygen

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study participation

- No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin)

- No other concurrent uncontrolled illness

- No active or ongoing infection

- No active second malignancy

- No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP or other study agents

- No psychiatric illness or social situation that would preclude study compliance

- At least 1 year since prior platinum-derivative agents

- No prior chemotherapy for metastatic or recurrent esophageal cancer

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered

- No other concurrent anticancer therapy

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
triapine
Given IV
cisplatin
Given IV

Locations

Country Name City State
United States University of Chicago Comprehensive Cancer Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete response rate Will be calculated together with 95% confidence intervals based on the binomial distribution. Up to 2 years No
Primary Objective response rate (CR + PR) Will be calculated together with 95% confidence intervals based on the binomial distribution. Up to 2 years No
Secondary Overall survival Kaplan-Meier estimates will be determined. Up to 2 years No
Secondary Progression-free survival Kaplan-Meier estimates will be determined. From the start of treatment to progression or death, assessed up to 2 years No
Secondary Duration of response From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years No
Secondary Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0 Up to 2 years Yes
Secondary Number of patients with improvement of dysphagia Up to 2 years No
Secondary Duration of improvement of dysphagia Up to 2 years No
See also
  Status Clinical Trial Phase
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Terminated NCT01249443 - Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Phase 1
Completed NCT01612546 - Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery Phase 2
Withdrawn NCT02344810 - C-Met Inhibitor AMG 337, Oxaliplatin, Leucovorin Calcium, and Fluorouracil in Treating Patients With Advanced Stomach or Esophageal Cancer Phase 1/Phase 2
Completed NCT01522820 - Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors Phase 1
Terminated NCT00061958 - Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction Phase 2
Terminated NCT00064259 - A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer Phase 1/Phase 2
Completed NCT00045526 - Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer Phase 2
Not yet recruiting NCT05856500 - A Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors N/A
Completed NCT01129206 - Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy Phase 2
Active, not recruiting NCT04670445 - Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer N/A
Completed NCT00607594 - Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer Phase 2
Completed NCT00397384 - Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Phase 1
Completed NCT01231399 - Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer Phase 1/Phase 2
Completed NCT00031681 - 7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007) Phase 1
Completed NCT00030498 - Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Phase 1
Active, not recruiting NCT03154190 - Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer N/A
Completed NCT00004074 - Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu Phase 1