Alvocidib in Treating Patients With Locally Advanced or Metastatic Solid Tumors

NCT00112684 | Terminated Phase 1 DMC

• 9 other identifiers: NCI-2009-00135OSU-2005C0009CDR0000429582NCI-7204OSU-04111OSU 041117204U01CA076576P30CA016058
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of alvocidib in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Alvocidib may also stimulate the immune system in different ways and stop tumor cells from growing. It may also stop the growth of solid tumors by blocking blood flow to the tumor.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Adverse events of dose escalated alvocidib administered in patients with advanced solid tumors

  Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  At weeks 1-4, 7-10, 11 or 12, and within 4 weeks after the completion of study treatment

Secondary Outcomes (4)

• Pharmacokinetics of alvocidib administered in this schedule

  After the first dose of treatment drug

• Immunomodulatory effects of alvocidib

  Baseline, days 1 and 15 of courses 1 and 2, and within 4 weeks after the completion of study treatment

• Pharmacogenomics studies on procured PBMCs if clinical responses are observed

  Baseline, and within 4 weeks after the completion of study treatment

• Measurement of serum tumor markers depending on the tumor type

  Baseline, week 11 or 12, and within 4 weeks after the completion of study treatment

Study Arms (1)

Treatment (chemotherapy, biological therapy)

EXPERIMENTAL

Patients receive alvocidib IV over 4½ hours once weekly in weeks 1-4. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: alvocidib; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

alvocidib DRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275

Treatment (chemotherapy, biological therapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (chemotherapy, biological therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemotherapy, biological therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed solid tumor
• Locally advanced or metastatic disease for which curative treatment does not exist or is no longer effective
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No previously irradiated\* measurable lesion unless lesion demonstrates progressive disease OR there are other measurable lesions outside the irradiated\* field
• The following are not considered measurable disease:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural or pericardial effusion
• Lymphangitis cutis/pulmonis
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• No uncontrolled brain metastases
• Performance status - ECOG 0-1
• At least 6 months

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

alvocidib

Study Officials

• Manisha Shah

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: February 1, 2006
• Primary Completion: July 1, 2012
• Last Updated: February 24, 2014

Record last verified: 2011-11

Locations

US (1)