Phase 1
N=12
Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00003377 ↗Enrolled (actual)
12
Serious AEs
13.8%
Results posted
Feb 2013
Primary outcome: Primary: Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment — 0; 0; 2; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- cisplatin (Drug); paclitaxel (Drug); brachytherapy (Radiation); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment |
0; 0; 2; 2; 0; 0 | — |
| SECONDARY Disease-free Survival at 2 Years |
0.65 | — |
| SECONDARY Overall Survival at 2 Years |
0.80 | — |
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven previously untreated invasive carcinoma of the uterine cervix
- Squamous cell carcinoma
- Adenosquamous carcinoma
- Adenocarcinoma
- TNM classification stage IIIB or IVA (FIGO classification stage IB, IIA, IIB, IIIA, IIIB, or IVA)
- Cytologically or histologically proven metastases to the para-aortic lymph nodes
- No more than 8 weeks since diagnosis
- No metastases to scalene nodes, intraperitoneal metastases, or metastases to other organs outside the radiation field at the time of original clinical and surgical staging
- Negative CT scan of the chest
- Patients with ureteral obstruction must be treated with stent or nephrostomy tube
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- GOG 0-2
Life expectancy:
- At least 6 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
Renal:
- Creatinine less than 2.0 mg/dL
- No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) requiring modification of radiation fields
Other:
- Not pregnant
- No septicemia or severe infection
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior cytotoxic chemotherapy for this or other malignancy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for this or other malignancy
- No prior radiotherapy to pelvis or abdomen
Surgery:
- Not specified
Other:
- No other prior therapy for this malignancy
Data sourced from ClinicalTrials.gov (NCT00003377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.