Clinical trial · Interventional
Vinorelbine and Paclitaxel Plus Radiation Therapy in Treating Patients With Advanced Cancer Arising in the Pelvis
Phase I Study of Concomitant Chemoradiotherapy With Vinorelbine and Paclitaxel in Patients With Advanced Pelvic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- 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)
- interventionNames
- Drug: paclitaxel
- Drug: vinorelbine tartrate
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available