Topotecan, Cisplatin, and Radiation Therapy in Treating Patients With Advanced Cervical Cancer

NCT00287911 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000452043UMN-2001LS041UMN-WCC-34104864/638
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Topotecan and cisplatin may make tumor cells more sensitive to radiation therapy. Giving topotecan and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with cisplatin and radiation therapy in treating patients with advanced cervical cancer.

Conditions

Cervical Cancer

Keywords

cervical adenocarcinoma; cervical adenosquamous cell carcinoma; cervical squamous cell carcinoma; stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of topotecan

  Adequate Response Trial Minimum length of trial to evaluate response is defined as receiving the first course of chemotherapy and living at least three weeks for repeat measurement to be performed.

  Week 3 After First Course of Therapy

Study Arms (1)

Combo Chemotherapy and Radiation

EXPERIMENTAL

Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Some patients may also undergo brachytherapy. Patients also receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36 and topotecan IV continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Drug: cisplatin; Drug: topotecan hydrochloride; Radiation: brachytherapy; Radiation: radiation therapy

Interventions

cisplatin DRUG

intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, and 36

Also known as: cisplatinum, CDDP, Platinol AQ

Combo Chemotherapy and Radiation

topotecan hydrochloride DRUG

intravenously continuously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36 -Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined

Also known as: Hycamtin

Combo Chemotherapy and Radiation

brachytherapy RADIATION

Some patients may also undergo brachytherapy

Combo Chemotherapy and Radiation

radiation therapy RADIATION

once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36

Also known as: radiation

Combo Chemotherapy and Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed cervical carcinoma
• Deemed not curable by surgery or radiotherapy alone
• The following stages are eligible:
• Stage IIB
• Stage IIIA or IIIB
• Stage IVA
• Stage IB or IIA with ≥ 1 of the following risk factors:
• Primary tumor ≥ 6 cm
• Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
• Positive surgical margins
• Depth of invasion \> 50% and positive capillary-lymphatic space involvement
• The following histologic subtypes are eligible:
• Squamous
• Adenosquamous
• Adenocarcinoma

You may not qualify if:

• Prior pelvic radiation
• Pregnant or nursing
• History of thrombus
• History of unstable angina or myocardial infarction within the past 6 months

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Topotecan; Brachytherapy; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics; Physical Phenomena

Study Officials

• Linda F. Carson, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: February 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

US (1)