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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
N/A
Open (Enrolling)
Female
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
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.

Type of Study:

Interventional

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:

Yes

Principal Investigator

Bradley Monk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UCI 03-33

NCT ID:

NCT00257816

Start Date:

April 2004

Completion Date:

January 2009

Related Keywords:

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

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868