NCT00006245

Brief Summary

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 cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining flavopiridol and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer that has not responded to previous paclitaxel therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

June 24, 2013

Status Verified

April 1, 2004

First QC Date

September 11, 2000

Last Update Submit

June 20, 2013

Conditions

Esophageal Cancer

Keywords

stage III esophageal cancerstage IV esophageal cancerrecurrent esophageal cancersquamous cell carcinoma of the esophagusadenocarcinoma of the esophagus

Interventions

alvocidibDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or carcinoma of the gastroesophageal (GE) junction * If tumor extends below the GE junction into the proximal stomach, 50% of the tumor must involve the esophagus or GE junction * No gastric cancers with only a minor involvement of the GE junction or distal esophagus * Metastatic or locally advanced disease that is considered surgically unresectable * Must have failed a prior chemotherapy regimen that included paclitaxel for metastatic disease OR * Failed prior combination taxane-based chemotherapy and radiotherapy for locally advanced disease * Must have documented evidence of the following: * Disease progression while on taxane-based neoadjuvant or adjuvant therapy OR * Recurrent disease within 6 months of therapy * Measurable disease * Accurately measured in at least 1 dimension * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * The following are considered nonmeasurable: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusions * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * No brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 150,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No active angina or myocardial infarction within the past 6 months * No significant ventricular arrhythmia requiring antiarrhythmic medication * Atrial fibrillation that is well controlled on standard management allowed Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study * No preexisting peripheral neuropathy of grade 2 or greater * No serious concurrent infection * No uncontrolled, nonmalignant medical illness that would preclude study * HIV negative * No other active malignancy within the past 5 years except: * Nonmelanoma skin cancer or * Carcinoma in situ of the cervix * History of T1a or T1b prostate cancer (detected incidentally during transurethral resection of the prostate and comprising less than 5% of resected tissue) allowed if PSA normal since surgery * No medical or psychiatric condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * See Disease Characteristics * No more than 6 months since prior paclitaxel * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * Prior radiotherapy allowed (indicator lesion must be outside of prior radiation port unless recent evidence of disease progression at that site) * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No prior cyclin-dependent kinase or protein kinase C inhibitors for esophageal cancer * Recovered from toxic effects of any prior therapy * No concurrent vitamins, antioxidants or herbal preparations or supplements

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Rathkopf DE, Ilson DH, Yi S, et al.: A phase II trial of sequential paclitaxel and flavopiridol in patients with metastatic paclitaxel-refractory esophageal cancer. [Abstract] American Society of Clinical Oncology 2004 Gastrointestinal Cancers Symposium, 22-24 January 2004, San Francisco, CA. A-67, 2004.

    RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAdenocarcinoma Of Esophagus

Interventions

alvocidibPaclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Gary K. Schwartz, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

July 1, 2000

Study Completion

August 1, 2007

Last Updated

June 24, 2013

Record last verified: 2004-04

Locations

US(1)