Combination Chemotherapy in Treating Patients With Advanced Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have advanced cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cisplatin Drug: triapine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin |
| Study Start Date: | March 2001 |
OBJECTIVES:
- Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the antitumor responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of cisplatin.
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed progressive malignant disease that has failed at least 1 conventional treatment or is unlikely to respond to current therapy
Measurable or evaluable disease
- Elevated serum tumor marker considered evaluable disease
No known active CNS metastases
- Previously treated CNS metastases with no evidence of new CNS metastases allowed if stable for at least 2 months
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL (transfusion allowed)
- No active bleeding or coagulation disorder (except occult blood related to gastrointestinal cancer)
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- ALT and AST no greater than 3 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 5 times ULN
- PT and PTT no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No active heart disease
- No myocardial infarction within the past 3 months
- No symptomatic coronary artery disease
- No uncontrolled arrhythmias
- No uncontrolled congestive heart failure
Pulmonary:
- No moderate to severe compromise of pulmonary function
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infectious process
- No pre-existing severe hearing impairment
- No grade 2 or greater neuropathy
- No other life threatening illness
- No prior severe allergic reaction to cisplatin
- No mental deficits and/or psychiatric history that would preclude study
- No persistent chronic toxic effects from prior chemotherapy greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 2 weeks since prior biologic therapy
Chemotherapy:
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- At least 3 months since prior cisplatin or platinum analogue
- No prior 3-AP
Endocrine therapy:
- At least 2 weeks since prior hormonal therapy
Radiotherapy:
- More than 3 weeks since prior radiotherapy
Surgery:
- At least 3 weeks since prior major surgery and recovered
Other:
- No other concurrent investigational drugs
- No other concurrent nephrotoxic drugs (e.g., aminoglycoside antibiotics)
Contacts and Locations| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| Study Chair: | Mario Sznol, MD | Vion Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00024323 History of Changes |
| Other Study ID Numbers: | CDR0000068918, VION-CLI-021, NCI-V01-1668 |
| Study First Received: | September 13, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Cisplatin Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013