NCT00257816

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2007

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

4 years

First QC Date

November 21, 2005

Last Update Submit

February 1, 2018

Conditions

Cervical Cancer

Keywords

Cervical CancerTopotecanCisplatin

Outcome Measures

Primary Outcomes (1)

  • Number of Participants in which topotecan improves response rate (RR) when added to cisplatin in treating metastatic and recurrent cervical cancer

    Topotecan improves response rate (RR), progression-free survival (PFS) and overall survival (OS) when added to cisplatin in treating metastatic and recurrent cervical cancer. The objective of this study was to assess the feasibility of adding weekly topotecan to cisplatin in patients with primary, locally advanced carcinoma of the cervix receiving pelvic irradiation.

    5 years

Secondary Outcomes (2)

  • Number of Participants in which topotecan improves progression-free survival (PFS) when added to cisplatin in treating metastatic and recurrent cervical cancer.

    5 years

  • Number of Participants in which topotecan improves overall survival (OS) when added to cisplatin in treating metastatic and recurrent cervical cancer.

    5 years

Study Arms (1)

Topotecan

EXPERIMENTAL

Adding weekly topotecan to cisplatin in patients with primary, locally advanced carcinoma of the cervix receiving pelvic irradiation.

Drug: TopotecanDrug: Cisplatin

Interventions

TopotecanDRUG

(First stage of accrual, 6 patients)-2 mg/m2 IV on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles) If none or 1 of the 6 patients in the first Stage of accrual finish the prescribed therapy in over 8 weeks, then the second Stage of accrual (an additional 6 patients) will increase the Topotecan dose to 3 mg/m2 on days 1, 8, 15, 22, 29 and once during parametrical boost (6 cycles). If 2 or 3 of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, the dose of the Topotecan will remain the same in the second Phase of accrual. If 4 or more of the patients in the first stage of accrual finish the prescribed therapy in over 8 weeks, there will be no second phase of accrual.

Also known as: Hycamtin
Topotecan
CisplatinDRUG

40 mg/m2 IV (Maximum total dose of 70 mg) on days 1, 8, 15, 22, 29 and once during parametrial boost (6 cycles)

Also known as: Platinol, AQ, NSC #119875
Topotecan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patients with negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT, MRI or lymphadenectomy.
  • 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.
  • Patients with adequate renal function: Creatinine equal to or less than 1.5 mg%.
  • 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.
  • Patients who have signed an approved informed consent.
  • Patients with GOG Performance Status of 0, 1, 2, or 3.
  • Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
  • Patients who are suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation.

You may not qualify if:

  • Patients who cannot be or have not been adequately clinically staged.
  • Patients with lower one-third vaginal involvement.
  • Patients with septicemia or severe infection.
  • Patients with circumstances that will not permit completion of the study or required follow-up.
  • 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.
  • Patients with carcinoma of the cervical stump.
  • Patients who are lactating or pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Related Publications (1)

  • Gatcliffe TA, Tewari KS, Shah A, Brewster WR, Burger RA, Kuo JV, Monk BJ. A feasibility study of topotecan with standard-dose cisplatin and concurrent primary radiation therapy in locally advanced cervical cancer. Gynecol Oncol. 2009 Jan;112(1):85-9. doi: 10.1016/j.ygyno.2008.09.029. Epub 2008 Nov 1.

    PMID: 18977518RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

TopotecanCisplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Bradley Monk, MD

    Chao Family Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cancer Center

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 23, 2005

Study Start

January 1, 2004

Primary Completion

December 17, 2007

Study Completion

December 17, 2007

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

US(1)