Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
Completed · Phase 2
Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Recurrent Cervical Carcinoma
In brief
Phase II trial to study the effectiveness of capecitabine in treating patients who have persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Key facts
- Study ID
- NCT00039442
- Run by
- Gynecologic Oncology Group
- People needed
- 21
- Starts
- 2002-04-29
- Last updated by the study team
- 2017-08-24
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix
- Persistent or recurrent disease
- Eligible subtypes include:
- Adenocarcinoma
- Adenosquamous cell carcinoma
- Undifferentiated carcinoma
- Documented disease progression
- At least 1 unidimensionally measurable target lesion outside prior irradiation field
- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, and MRI)
- At least 10 mm by spiral CT scan
- Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent non-SCC of the cervix
- Radiosensitizing chemotherapy administered in combination with primary radiotherapy is not counted as a systemic chemotherapy regimen
- Tissue blocks from initial diagnosis, metastasis, or recurrence available for submission to the GOG tissue bank
- Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), defined as any Temporarily closed GOG phase III protocol for the same patient population
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine clearance at least 50 mL/min
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No Temporarily closed infection requiring antibiotics
Where it is running
- Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.