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Feasibility Study of Weekly IV Topotecan and Cisplatin With Concurrent Pelvic Radiation in the Treatment of Stages IB2 - IVA Cervical Carcinoma

Phase 2
18 Years
Open (Enrolling)
Cervical Cancer

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Trial Information

Feasibility Study of Weekly IV Topotecan and Cisplatin With Concurrent Pelvic Radiation in the Treatment of Stages IB2 - IVA Cervical Carcinoma

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the feasibility and toxicity

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Bradley Monk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

UCI 03-33



Start Date:

April 2004

Completion Date:

January 2009

Related Keywords:

  • Cervical Cancer
  • Cervical Cancer
  • Carcinoma
  • Uterine Cervical Neoplasms



Chao Family Comprehensive Cancer CenterOrange, California  92868