NCT00002949

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy with may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy with vinorelbine and paclitaxel plus radiation therapy in treating patients with advanced cancer arising in the pelvis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 1996

Longer than P75 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

4.3 years

First QC Date

November 1, 1999

Last Update Submit

September 4, 2013

Conditions

Bladder CancerCervical CancerEndometrial CancerVaginal Cancer

Keywords

stage II cervical cancerstage III cervical cancerstage IV cervical cancerstage II vaginal cancerstage III vaginal cancerstage IVA vaginal cancerstage IVB vaginal cancerstage II endometrial carcinomastage III endometrial carcinomastage IV endometrial carcinomastage II bladder cancerstage III bladder cancerstage IV bladder cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    4 years

Study Arms (1)

Arm A

EXPERIMENTAL

Vinorelbine (qwk, 10, 15, 20 or 25 mg/m2), Radiation therapy (Total pelvic RT of 45 Gy in 1.8-Gy daily fractions, 85 Gy in cervical cancer patients using intracavitary brachytherapy, 70 Gy in patients treated with interstitial brachytherapy) Paclitaxel (qwk, starting dose of 20mg/m2 with planned dose escalation increments of 5mg/m2)

Drug: paclitaxelDrug: vinorelbine tartrateRadiation: radiation therapy

Interventions

paclitaxelDRUG

Paclitaxel (qwk, starting dose of 20mg/m2 with planned dose escalation increments of 5mg/m2)

Arm A
vinorelbine tartrateDRUG

Vinorelbine (qwk, 10, 15, 20 or 25 mg/m2),

Arm A
radiation therapyRADIATION

Radiation therapy (Total pelvic RT of 45 Gy in 1.8-Gy daily fractions, 85 Gy in cervical cancer patients using intracavitary brachytherapy, 70 Gy in patients treated with interstitial brachytherapy)

Arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced carcinoma of the uterine cervix, vagina, or bladder or other pelvic malignancy for which whole pelvic radiation therapy is planned Metastatic disease is permitted PATIENT CHARACTERISTICS: Age: Over 18 Performance status: CALGB 0-2 Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal limits Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No unstable angina or myocardial infarction in previous 6 months Other: Not pregnant No significant concomitant illness, uncontrolled infection, or cirrhosis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior whole pelvic radiation therapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsVaginal Neoplasms

Interventions

PaclitaxelVinorelbineRadiotherapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesVaginal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTherapeutics

Study Officials

  • Gini F. Fleming, MD

    University of Chicago

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 16, 2004

Study Start

July 1, 1996

Primary Completion

November 1, 2000

Study Completion

May 1, 2001

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)