Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
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ClinicalTrials.gov Identifier: NCT00079352 |
Recruitment Status
:
Completed
First Posted
: March 10, 2004
Last Update Posted
: January 25, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific | Drug: alvocidib Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride | Phase 1 |
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic solid tumors.
II. Determine the toxicity profile of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | October 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (gemcitabine, irinotecan, alvocidib)
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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Drug: alvocidib
Given IV
Other Names:
Drug: gemcitabine hydrochloride
Given IV
Other Names:
Drug: irinotecan hydrochloride
Given IV
Other Names:
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- Recommended phase II dose of flavopiridol defined as the highest dose for which no more than one patient develop a >= grade 3 toxicity [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed solid tumor that is metastatic or unresectable
- Standard curative or palliative measures do not exist or are no longer effective
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- No venous thrombosis within the past 6 months
- No thrombotic cerebrovascular accident within the past 6 months
- No myocardial infarction within the past 6 months
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No ongoing or active infection
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents
- No other concurrent uncontrolled medical condition that would preclude study participation
- No psychiatric illness or social situation that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Prior biologic therapy allowed
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior endocrine therapy allowed
- More than 4 weeks since prior radiotherapy and recovered
- Prior surgery allowed
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079352
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87106 |
Principal Investigator: | Ian Rabinowitz | University of New Mexico |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079352 History of Changes |
Other Study ID Numbers: |
NCI-2012-02580 UNM-0903C CDR0000355358 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | March 10, 2004 Key Record Dates |
Last Update Posted: | January 25, 2013 |
Last Verified: | January 2013 |
Additional relevant MeSH terms:
Gemcitabine Irinotecan Camptothecin Alvocidib Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents |
Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Growth Inhibitors Growth Substances Protein Kinase Inhibitors |