Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
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Purpose
This phase II trial is studying how well triapine works as first-line or second-line therapy in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the pancreas. Drugs used in chemotherapy, such as triapine, work in different ways to stop tumor cells from dividing so they stop growing or die
| Condition | Intervention | Phase |
|---|---|---|
|
Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer |
Drug: triapine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas |
- Survival in patients receiving triapine as first-line therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]The point estimate of the success rates will be calculated as the number of successes divided by the number of evaluable patients, with confidence intervals calculated by the method of Duffy and Santner.
- Survival in patients receiving triapine as second-line therapy [ Time Frame: 4 months ] [ Designated as safety issue: No ]The point estimate of the success rates will be calculated as the number of successes divided by the number of evaluable patients, with confidence intervals calculated by the method of Duffy and Santner.
- Incidence of adverse events assessed using CTCAE version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
- Time to treatment failure [ Time Frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 3 years ] [ Designated as safety issue: No ]The distribution of time to progression will be estimated using the method of Kaplan-Meier.
- Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart [ Time Frame: 6 months (first 6 courses of treatment) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 116 |
| Study Start Date: | July 2004 |
| Estimated Primary Completion Date: | January 2100 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (triapene)
Patients receive triapene IV over 2 hours on days 1-4 and 15-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Drug: triapine
Given IV
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the 3- and 6-month survival rate of patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with 3-AP (Triapine^®) as first- or second-line therapy.
SECONDARY OBJECTIVES:
I. Determine the toxicity and tolerability of this drug in these patients. II. Determine the time to treatment failure in patients treated with this drug. III. Determine overall survival and disease progression in patients treated with this drug.
IV. Determine tumor response in patients treated with this drug. V. Determine laboratory studies that will increase our understanding of Triapine and its effects on cellular processes.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no).
Patients receive triapene IV over 2 hours on days 1-4 and 15-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months for 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Unresectable disease
- Locally advanced or metastatic disease
At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- Measurable lesions outside prior radiotherapy field OR measurable lesions actively growing in the site of prior radiotherapy
No prior chemotherapy OR previously treated with 1, and only 1, gemcitabine-containing regimen for metastatic, unresectable, or locally advanced pancreatic cancer
- Adjuvant therapy not considered prior chemotherapy if all treatment was completed > 6 months before tumor recurrence
- No known brain metastases
- Performance status - ECOG 0-2
- At least 6 weeks
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 75,000/mm^3
- AST =< 3 times upper limit of normal (ULN)
- Bilirubin =< 1.5 times ULN
- Creatinine =< 1.5 times ULN
- Creatinine clearance > 60 mL/min
- No uncontrolled congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No pulmonary disease requiring oxygen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin or ancestry)
- No active or ongoing infection
- No hypersensitivity or severe allergic reaction to 3-AP (Triapine®) or related compounds
- No concurrent uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent antineoplastic therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational therapy for the malignancy
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00085371 History of Changes |
| Other Study ID Numbers: | NCI-2012-01452, MC0345, N01CM62205, CDR0000368762 |
| Study First Received: | June 10, 2004 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Pancreatic Neoplasms Carcinoma, Acinar Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Neoplasms |
Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013