Vinorelbine and Paclitaxel Plus Radiation Therapy in Treating Patients With Advanced Cancer Arising in the Pelvis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT00002949
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • paclitaxel — DRUG
    Paclitaxel (qwk, starting dose of 20mg/m2 with planned dose escalation increments of 5mg/m2)
  • vinorelbine tartrate — DRUG
    Vinorelbine (qwk, 10, 15, 20 or 25 mg/m2),
  • radiation therapy — RADIATION
    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)

Study Details

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.

Key Dates

Start date
Jul 31, 1996
Status verified
Sep 2013
Primary completion
Nov 30, 2000
Completion
May 31, 2001

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    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)

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Cancer Research CenterChicagoIllinois60637-

Find similar trials in Chicago, IL

By condition
Bladder cancerCervical cancerEndometrial cancer
By specialty
OncologyUrologyGynecologic oncologyWomen's health
By research site
University of Chicago Cancer Research Center· Chicago, IL

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