Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer

NCT00316173 | Completed Phase 2 Results DMC

• 1 other identifier: 104864/902
• Study Type: interventional
• Target: 77
• Locations: 2 countries
• Sites: 22

Brief Summary

This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.

Conditions

Ovarian Cancer; Neoplasms, Ovarian

Keywords

HYCAMTIN; ovarian cancer; recurrent; relapsed; carboplatin; topotecan; potentially platinum-sensitive

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Indicated Response

  Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization \[WHO\] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: \>50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: \>25% increase in measurements of lesions or appearance of new lesions).

  From start of treatment to evidence of CR or PR (up to 39.3 weeks).

Secondary Outcomes (6)

• Time to Response

  From start of treatment to evidence of PR or CR (up to 39.3 weeks)

• Duration of Response

  From time of PR or CR to disease progression/death (up to 56.0 weeks)

• Progression-free Survival

  From start of treatment to disease progression/death (up to 67.7 weeks)

• Number of Participants Who Died From the Start of Treatment to Follow-up

  From start of treatment to death (up to 110.4 weeks).

• The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)

  Baseline to end of study (up to 54.7 weeks).

Study Arms (1)

Single-arm

EXPERIMENTAL

HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days

Drug: topotecan; Drug: CARBOPLATIN

Interventions

topotecan DRUG

HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1

Single-arm

CARBOPLATIN DRUG

HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1

Single-arm

Eligibility Criteria

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

You may qualify if:

• Subject must have baseline laboratory values as follows:
• Hemoglobin 9.0 g/dL
• Neutrophils 1,500/mm3
• Platelets 100,000/mm3
• Creatinine 1.5 mg/dL ( 133 mol/l) or creatinine clearance 60 mL/min
• Serum bilirubin \< 2.0 mg/dL (\< 35 umol/L)
• SGOT/AST, SGPT/ALT and alkaline phosphatase \< 2 times ULN if liver metastases are absent by abdominal CT or MRI or \< 5 times ULN if liver metastases are present
• Subject is allowed to have received, but is not required to have received, one additional prior non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
• Subject is female 18 years of age with an ECOG Performance Status of 0, 1 or 2
• Subject has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer which was histologically confirmed at the time of the primary diagnosis
• Subject has received one prior platinum-based chemotherapeutic regimen (containing either carboplatin or cisplatin) for the treatment of primary disease. Consolidation chemotherapy is not permitted
• Subject's disease is considered potentially platinum-sensitive (i.e., have had a platinum-free interval following complete response to carboplatin or cisplatin of greater than 6 months)
• Subject must have at least one measurable lesion as determined by diagnostic studies including CT or MRI or physical exam. Measurable disease must be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be 20 mm in their longest dimension when measured by conventional techniques, including palpation, plain X-ray, CT and MRI, or 10 mm when measured by spiral CT. Palpable tumor masses that cannot be evaluated radiologically must have 2 diameters 20 mm. An attempt to document lesion size by ultrasound should be undertaken for palpable lesions not visualized on CT (or MRI).
• The same diagnostic imaging method used to evaluate disease must be used throughout the study to evaluate lesions consistently
• Stable blood, liver and renal functions.

You may not qualify if:

• Pregnant or lactating.
• Subject has received more than 1 prior chemotherapy regimen or a history of consolidation cytotoxic chemotherapy
• Subject has concomitant or history of previous malignancies, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for 5 years
• Subject has brain metastases as documented by CT or MRI. Note: Asymptomatic subjects do not require CT or MRI to rule out brain metastases
• Received previous treatment with HYCAMTIN.
• Subject has received an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to study entry
• Received prior radiation therapy for ovarian cancer

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Los Angeles, California, 90033, United States

Location

GSK Investigational Site

Orange, California, 92868, United States

Location

GSK Investigational Site

Poway, California, 92064, United States

Location

GSK Investigational Site

Stanford, California, 94305, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06520, United States

Location

GSK Investigational Site

Savannah, Georgia, 21404, United States

Location

GSK Investigational Site

South Bend, Indiana, 46617, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89109, United States

Location

GSK Investigational Site

Albany, New York, 12208, United States

Location

GSK Investigational Site

Brightwaters, New York, 11718, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599-7570, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28203, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44109-1998, United States

Location

GSK Investigational Site

Mayfield Heights, Ohio, 44124, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29605, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84112-5550, United States

Location

GSK Investigational Site

Seattle, Washington, 98101, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53215, United States

Location

GSK Investigational Site

Calgary, Alberta, T2N 4N2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

GSK Investigational Site

Québec, Quebec, G1R 2J6, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Rose PG, Monk BJ, Provencher D, Hartney J, Legenne P, Lane S. An open-label, single-arm Phase II study of intravenous weekly (Days 1 and 8) topotecan in combination with carboplatin (Day 1) every 21 days as second-line therapy in patients with platinum-sensitive relapsed ovarian cancer. Gynecol Oncol. 2011 Jan;120(1):38-42. doi: 10.1016/j.ygyno.2010.10.011. Epub 2010 Nov 5.

  PMID: 21055798 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

Topotecan; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Limitations and Caveats

As only 17 of 55 participants had CR/PR, the treatment was not effective. The follow up of participants for survival was thus stopped early (original plan: every 3 months for 2 years; then every 6 months for 3-5 years; then annually/until death).

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 20, 2006
• Study Start: March 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 27, 2012
• Results First Posted: November 26, 2009

Record last verified: 2012-11

Locations

US (18); CA (4)