Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Topotecan Type: Drug
Name: Cisplatin Type: Drug
Overall Status
Recruiting
Summary
There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with improvements in durable remissions and overall survival. Though the incidence and mortality in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau, arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to local regional radiation, mortality from advanced cervical cancer in the United States is expected to further decrease. However, further advances in this disease are needed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage I-2, II-B, III-B, IV-A.

2. Patients with negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT, MRI or lymphadenectomy.

3. Patients with adequate bone marrow function: ANC greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl, and Hemoglobin > 10 mg/dl.

4. Patients with adequate renal function: Creatinine equal to or less than 1.5 mg%.

5. Patients with adequate hepatic function: Bilirubin less than or equal to 1.5 x normal and SGOT and Alkaline phosphatase less than or equal to 3 x normal.

6. Patients who have signed an approved informed consent.

7. Patients with GOG Performance Status of 0, 1, 2, or 3.

8. Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.

9. Patients who are suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation.

Exclusion Criteria:

1. Patients who cannot be or have not been adequately clinically staged.

2. Patients with lower one-third vaginal involvement.

3. Patients with septicemia or severe infection.

4. Patients with circumstances that will not permit completion of the study or required follow-up.

5. Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.

6. Patients with carcinoma of the cervical stump.

7. Patients who are lactating or pregnant.
Location
Chao Family Comprehensive Cancer Center
Orange, California, United States
Status: Recruiting
Start Date
April 2004
Completion Date
January 2009
Sponsors
University of California, Irvine
Source
University of California, Irvine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page