Study of Cisplatin in Cervical Cancer Stage IVB - Full Text View

Sponsored by:	Chinese Anti-Cancer Association
Information provided by:	Chinese Anti-Cancer Association
ClinicalTrials.gov Identifier:	NCT00826891

Purpose

This is a single arm, open-label study in women from China who have Advanced (stage IVB) Recurrent or Persistent cervical cancer to ⑴assess the response rate (i.e., CR + PR) of Cisplatin combined with Topotecan in treatment of advanced (stage IVB) recurrent or persistent Cervical cancer; ⑵assess the toxicities of CT regimen in treatment of cervical cancer. Prior to treatment, written informed consent should be obtained from all patients. Eligible patients will be assigned to CT regimen. The CT regimen is topotecan 0.75 mg/m2 IV during 30minutes days 1, 2, and 3; followed by cisplatin 50 mg/m2 IV on day1, repeated every 21 days. The study will consist of two phases: the safety run-in phase and study phase.

Condition	Intervention	Phase
Cervical Cancer	Drug: Cisplatin Combined With Topotecan	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer

Further study details as provided by Chinese Anti-Cancer Association:

Primary Outcome Measures:

Response rate (CR + PR) (RECIST) [ Time Frame: 4~6 weeks after the end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Toxicity [NCI CTCAE (Version 3.0)] [ Time Frame: 4~6 weeks after the end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	February 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Patients must have specific minimum neutrophil and platelet counts before administration of Hycamtin. The dose of Hycamtin is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course). Dosage adjustments for subsequent courses of Hycamtin in combination with cisplatin are specific for each drug.

Dose levels for cisplatin Initial dose 0 = 50 mg/m2 Dose reduction level -1 = 37.5 mg/m2 Dose reduction level -2 = 25 mg/m2

Dose levels for topotecan Initial dose 0 = 0.75 mg/m2 Dose reduction level -1 = 0.60 mg/m2 Dose reduction level -2 = 0.45 mg/m2

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

women with advanced recurrent or persistent carcinoma of the uterine cervical who were unsuitable candidates for curative treatment with surgery and/or radiotherapy.
Histologic types included squamous, adenosquamous, and adenocarcinoma of the cervia.
Patients must be at least 18 years old.
Measurable and/or evaluable disease parameters will be documented and recorded using clinical evaluation (and using CT for pathologic nodes when present).
Life expectation greater than 3 months.
Patients must have adequate organ function.
Patients without history of sensitivity to camptothecin or platinum.
Patients who are non-child-bearing potential, or consistent and correct use of methods of birth control from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of observational medication.
performance status 0 to 2; to have recovered from the effects of recent surgery, chemoradiotherapy, or radiotherapy; and to be free of clinically significant infection.
Written informed consent

Exclusion Criteria:

Patients with uncontrolled infections.
Patients with concurrent severe medical problems unrelated to the malignancy which would expose the patient to extreme risk.
Patients who received another investigational drug within 30 days prior to study entry.
Patients who are receiving concurrent other chemotherapy, hormonal, immunotherapy or radiotherapy. Radiotherapy for palliation of related bone metastases is permitted.
Patients with a history of allergic reactions to compounds chemically related to topotecan or platinum.
Patients who are pregnant or lactating
Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Chinese Anti-Cancer Association ( xuan guo )
Study ID Numbers:	CACA-2008-GSK1
Study First Received:	January 16, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00826891 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin
Topotecan
Recurrence

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Cisplatin
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Enzyme Inhibitors
Topotecan
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009