Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - Full Text View

Sponsor:	NHS Greater Glasgow and Clyde
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00098878

Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC, stage II, stage III, or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: carboplatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	SCOTROC 4: A Prospective, Multicentre, Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian, Fallopian Tube And Primary Peritoneal Cancers

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Quality of life [ Designated as safety issue: No ]
Clinical overall response rate and CA125 response [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	1300
Study Start Date:	March 2004
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare progression-free survival of patients with stage IC-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy.

Secondary

Compare the toxic effects of these regimens in these patients.
Compare the quality of life of patients treated with these regimens.
Compare overall clinical response rate and CA 125 response in patients treated with these regimens.
Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive a flat dose of carboplatin on day 1.
Arm II: Patients receive intra-patient dose-escalated carboplatin on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each treatment course, and then at 2 months post-chemotherapy.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer*
- Stage IC-IV disease
- Peritoneal carcinomatosis* (ovarian-type) must not be a mucin-secreting tumor
- Stage IC patients must have malignant cells in ascitic fluid or peritoneal washings, tumor on the surface of the ovary, or preoperative capsule rupture NOTE: * Histologic confirmation of a primary source in the ovary is not required.
If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met:
- Patient has a pelvis (ovarian) mass AND all of the following:
  - Omental cake or other metastasis is larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size OR stage IV disease
  - Serum CA 125/CEA ratio > 25 or barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) are negative for the presence of a primary tumor and normal mammography within 6 weeks prior to study randomization
Initial cytoreductive laparotomy or biopsy required within the past 8 weeks
- Cytoreductive surgery may or may not have been successful during staging laparotomy
No mixed mesodermal tumors
No borderline ovarian tumors or tumors termed "possibly malignant"
No adenocarcinoma of unknown origin, if histologically confirmed to be a mucin-secreting tumor
Considered unsuitable for or unwilling to receive platinum-taxane combination therapy
No concurrent endometrial cancer

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-3

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin normal
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 5 times ULN

Renal

Creatinine clearance ≥ 30 mL/min
- Obstructive hydronephrosis as a cause of borderline (i.e., creatinine clearance 30-45 mL/min) renal function must be treated before study entry

Cardiovascular

No hypertension
No ischemic heart disease
No myocardial infarction within the past 6 months
No congestive heart failure

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No symptomatic peripheral neuropathy ≥ grade 2
No uncontrolled infection
No other severe and/or uncontrolled medical condition
No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy
No other concurrent cytotoxic chemotherapy until progressive disease occurs

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098878

Show 88 Study Locations

Sponsors and Collaborators

NHS Greater Glasgow and Clyde

Investigators

Study Chair:

Stanley B. Kaye, MD, FRCP

Royal Marsden NHS Foundation Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00098878 History of Changes
Other Study ID Numbers:	CDR0000396778, SCOTTISH-SCOTROC-4, EU-20402
Study First Received:	December 8, 2004
Last Updated:	July 8, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer

stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms

Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012